<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041090</url>
  </required_header>
  <id_info>
    <org_study_id>SLU IRB # 26741</org_study_id>
    <nct_id>NCT03041090</nct_id>
  </id_info>
  <brief_title>Patterns and Prevalence of FDG Extravasation in PET/CT Scans</brief_title>
  <acronym>Lucerno device</acronym>
  <official_title>Patterns and Prevalence of 18F-2-fluoro-2-deoxy-D-glucose (FDG) Extravasation in Positron Emission Tomography (PET)/ Computed Tomography (CT) Scans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lucerno Dynamics Limited Liability Company (LLC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PET (Positron Emission Tomography) images are used to help make patient management decisions&#xD;
      in staging and treatment assessment, often after a cancer diagnosis.&#xD;
&#xD;
      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is&#xD;
      known as extravasation or infiltration, and it compromises the doctor's ability to read the&#xD;
      PET image. Often, the site where the tracer is injected into the vein (usually in the inside&#xD;
      of the elbow) are not in the images taken, so reading physicians are unaware that an&#xD;
      extravasation or infiltration has occurred.&#xD;
&#xD;
      Technology exists to capture time activity curves (amount of tracer in a location over a&#xD;
      period of time) during the PET tracer uptake period (usually once the tracer is injected, the&#xD;
      tracer circulates for 60 minutes prior to images), which can enable physicians to accurately&#xD;
      detect extravasations and infiltration. This information is currently unavailable to&#xD;
      physicians reading routine PET/CT (computed tomography) scans.&#xD;
&#xD;
      Time activity curves information gathered from these sensors during the circulation period&#xD;
      appear to match the brief pictures taken approximately 70 minutes after the tracer injection.&#xD;
&#xD;
      This study will determine if these time activity curves correspond to PET images of the&#xD;
      injection site taken during the tracer uptake period. If time activity curves correspond to&#xD;
      PET images, they can be used to determine if the tracer was properly injected. If there was&#xD;
      an improper injection, clinicians can be alerted to this fact and interpret the image with&#xD;
      this additional information.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PET (Positron Emission Tomography) images are used to help make patient management decisions&#xD;
      in staging and treatment assessment, often after a cancer diagnosis.&#xD;
&#xD;
      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is&#xD;
      known as extravasation or infiltration, and it compromises the doctor's ability to read the&#xD;
      PET image. Often, the site where the tracer is injected into the vein (usually in the inside&#xD;
      of the elbow) are not in the images taken, so reading physicians are unaware that an&#xD;
      extravasation or infiltration has occurred.&#xD;
&#xD;
      Technology exists to capture time activity curves (amount of tracer in a location over a&#xD;
      period of time) during the PET tracer uptake period (usually once the tracer is injected, the&#xD;
      tracer circulates for 60 minutes prior to images), which can enable physicians to accurately&#xD;
      detect extravasations. This information is currently unavailable to physicians reading&#xD;
      routine PET/CT scans.&#xD;
&#xD;
      Time activity curves information gathered from these sensors during the circulation period&#xD;
      appear to match the brief pictures taken approximately 70 minutes after the tracer injection.&#xD;
&#xD;
      This study will determine if these time activity curves correspond to PET images of the&#xD;
      injection site taken during the tracer uptake period. If time activity curves correspond to&#xD;
      PET images, they can be used to determine if the tracer was properly injected. If there was&#xD;
      an improper injection, clinicians can be alerted to this fact and interpret the image with&#xD;
      this additional information.&#xD;
&#xD;
      In oncology, whole-body PET/CT is typically performed from the head to the pelvic floor (eyes&#xD;
      to thighs). The use of the term whole-body is misleading because the most commonly used field&#xD;
      of view (FOV) for arms-up whole-body PET/CT protocols includes only the base of skull to the&#xD;
      upper thighs and does not include the brain, skull, and large portions of both upper and&#xD;
      lower extremities. In such FOV, the most commonly used site of injection, namely the&#xD;
      antecubital fossa (inside of the elbow), is frequently not included in the imaging field. In&#xD;
      the Frontiers in Oncology article, Osman also determined that based on the commonly used FOV&#xD;
      at most PET/CT centers, that when infiltration is present, it may be unnoticed by clinicians&#xD;
      in approximately 31% of the cases.&#xD;
&#xD;
      Lucerno Dynamics, a privately held company in North Carolina, has also discovered that the&#xD;
      static image may be incapable of reporting on the quality of FDG administration during the&#xD;
      ~60 minute uptake period. Lucerno's system has been used in two investigational studies at&#xD;
      two centers. At one center, the system was used with 8 patients for a total of 15 scans. At&#xD;
      the other center, the system was used with 40 patients for a total of 85 scans. Similar rates&#xD;
      of infiltrations were found to those described in the published articles. Based on this&#xD;
      experience, Lucerno has found that infiltrations can partially resolve during the uptake&#xD;
      period, so that even if they are visible in the PET image, the image may not reveal the&#xD;
      extent of the infiltration. This could severely and negatively impact research and therapy&#xD;
      decisions and thus patient outcomes.&#xD;
&#xD;
      The Lucerno devices (Lucerno ID) are nonsignificant risk devices that add only 2-3 minutes to&#xD;
      the current standard of care PET/CT scanning process. Lucerno ID sensors are applied to the&#xD;
      patient's skin before the injection of the radiotracer and are removed after the FDG uptake&#xD;
      period and prior to the PET/CT imaging process. The Lucerno ID has the ability to identify&#xD;
      infiltrations, whether they are within or outside the FOV of reviewing clinicians, and can&#xD;
      alert clinicians before their patient undergoes a compromised PET/CT scan due to the&#xD;
      infiltration. This technology can prevent patients from receiving the additional CT radiation&#xD;
      exposure of a compromised scan, can save cost, and can improve patient outcomes by ensuring&#xD;
      more accurate PET scan interpretation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All participants are included in the static imaging arm. Some participants were also included in the dynamic imaging arm</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians</measure>
    <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
    <description>Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration</measure>
    <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
    <description>Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device</measure>
    <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
    <description>The percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Intravenous Infiltration</condition>
  <arm_group>
    <arm_group_label>Static Imaging participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of the study assessed participants' static PET/CT images. These were the standard of care images acquired after their standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.&#xD;
Intervention was Lucerno sensors (Lucerno Device Identity Document (LD ID), Lucerno Device 1 (LD1), Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dynamic image participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of the study assessed participants' dynamic PET/CT images. These were the study related images of and around the injection site acquired during the participants' standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.&#xD;
Intervention was Lucerno sensors (LD ID, LD1, Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lucerno ID (identification) System</intervention_name>
    <description>The Lucerno ID is intended to dynamically measure the uptake of radiotracer in a particular organ or body region during the radiotracer uptake period as part of nuclear medicine (NM) procedures. The Lucerno ID is indicated for use as a tool for trained healthcare professionals (technologists, NM physicians, and radiologists) to help assess whether a radiotracer injection has resulted in an infiltration. The LD ID can be used by healthcare professionals including nuclear medical technologists, nuclear medicine physicians, or any other medical staff in a NM facility, once they have received the necessary training into the use of the system.</description>
    <arm_group_label>Dynamic image participants</arm_group_label>
    <arm_group_label>Static Imaging participants</arm_group_label>
    <other_name>LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients ages 18-90.&#xD;
&#xD;
          -  Scheduled for a standard of care PET/CT scan at Sisters of Saint Mary (SSM) Saint&#xD;
             Louis University (SLU) Hospital&#xD;
&#xD;
          -  Willing to have self-adhesive sensors placed on the injections site, contralateral arm&#xD;
             in approximately the same position as the injection site, liver, and over the&#xD;
             subclavical area.&#xD;
&#xD;
          -  If consenting to imaging during the PET/CT uptake period, the patient must be able to&#xD;
             rest comfortably on the PET/CT scanning table for approximately 60 minutes during the&#xD;
             circulation of the tracer for additional PET only imaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons (male or female) under age 18&#xD;
&#xD;
          -  Persons with concerns about 4 adhesive sensors being placed on their bodies during the&#xD;
             uptake period.&#xD;
&#xD;
          -  Subjects unwilling to sign the consent document.&#xD;
&#xD;
          -  Subjects who cannot consent for themselves&#xD;
&#xD;
          -  Subjects who are not scheduled for a standard of care PET/CT exam at SLU hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SSM Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/29127247</url>
    <description>Published article: Novel Method to Detect and Characterize 18Fluoride-FDG Infiltration at the Injection Site: A Single-Institution Experience</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/29042469</url>
    <description>Published article: The Importance of Quality Control for Clinical PET Imaging</description>
  </link>
  <results_reference>
    <citation>Muzaffar R, Frye SA, McMunn A, Ryan K, Lattanze R, Osman MM. Novel Method to Detect and Characterize 18F-FDG Infiltration at the Injection Site: A Single-Institution Experience. J Nucl Med Technol. 2017 Dec;45(4):267-271. doi: 10.2967/jnmt.117.198408. Epub 2017 Nov 10.</citation>
    <PMID>29127247</PMID>
  </results_reference>
  <results_reference>
    <citation>Schaefferkoetter JD, Osman M, Townsend DW. The Importance of Quality Control for Clinical PET Imaging. J Nucl Med Technol. 2017 Dec;45(4):265-266. doi: 10.2967/jnmt.117.198465. Epub 2017 Oct 17. No abstract available.</citation>
    <PMID>29042469</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>April 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>November 29, 2018</results_first_submitted>
  <results_first_submitted_qc>June 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 14, 2019</results_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Medhat M. Osman, MD., Sc.M., Ph.D.</investigator_full_name>
    <investigator_title>Professor of Radiology; Director of Nuclear Medicine &amp; PET/CT</investigator_title>
  </responsible_party>
  <keyword>infiltration</keyword>
  <keyword>extravasation</keyword>
  <keyword>PET/CT</keyword>
  <keyword>PET</keyword>
  <keyword>PET-CT</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Coded data will be shared with our industry sponsor, Lucerno Dynamics</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03041090/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03041090/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Static Imaging Participants</title>
          <description>This arm of the study assessed participants' static Positron Emission Tomography / Computed Tomography (PET/CT) images. These were the standard of care images acquired after their standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data. This arm also visually assessed the images at the injection site by a board certified physician.</description>
        </group>
        <group group_id="P2">
          <title>Dynamic Image Participants</title>
          <description>This arm of the study assessed participants' dynamic Positron Emission Tomography / Computed Tomography (PET/CT) images. These were the study related images of and around the injection site acquired during the participants' standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data. This arm also visually assessed the images at the injection site by a board certified physician.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="21">3 consented subjects in the dynamic arm were not included in analysis due to technical errors.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>technical error</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data were analyzed by physician review of the static standard of care PET/CT images and dynamic injection site images for visible evidence of radiotracer infiltration. The Time Activity Curves (TACs) generated from the applied sensors were independently assessed and the results compared to physician assessments of the PET/CT images.</population>
      <group_list>
        <group group_id="B1">
          <title>Dynamic Arm</title>
          <description>Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. During the 60 minute uptake, these subjects were scanned. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. Dynamic arm (n=24 where 21 were analyzed) had 3 subjects that could not be analyzed due to technical errors, so 21 subjects were analyzed from this arm. Age and gender were not considered confounding factors and were not collected as part of the clinical study.</description>
        </group>
        <group group_id="B2">
          <title>Static Arm</title>
          <description>Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. The static arm included 109 subjects. Age and gender were not considered confounding factors and were not collected as part of the clinical study.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="109"/>
            <count group_id="B3" value="133"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>18 to 90 years (adults only). Participant age was not collected as part of this clinical study as long as these participants were within the 18 to 90 year range.</description>
          <population>Participant age was not included in analysis. The inclusion/exclusion criteria included that the subjects must be greater than or equal to 18 years and less than or equal to 90 years. Once the age was verified during the consent process, the specific age of the subject was not included in analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>The genders included in this study were male and female. Participant gender was not collected as part of this clinical study.</description>
          <population>Participant gender was not included in analysis. Al genders were included in the inclusion/exclusion criteria, so this data was not recorded nor included in analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="109"/>
                    <count group_id="B3" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Scheduled for a standard of care PET/CT</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="24"/>
                    <count group_id="B2" value="109"/>
                    <count group_id="B3" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians</title>
        <description>Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.</description>
        <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Arm</title>
            <description>This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.</description>
          </group>
          <group group_id="O2">
            <title>Static Arm</title>
            <description>This arm includes the study participants that participated in static image acquisition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians</title>
          <description>Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration</title>
        <description>Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site.</description>
        <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
        <population>The Time Activity Curve was studied that was provided from the sensor device among patients who underwent dynamic and static imaging.</population>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Arm</title>
            <description>This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.</description>
          </group>
          <group group_id="O2">
            <title>Static Arm</title>
            <description>This arm includes the study participants that participated in static image acquisition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration</title>
          <description>Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site.</description>
          <population>The Time Activity Curve was studied that was provided from the sensor device among patients who underwent dynamic and static imaging.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device</title>
        <description>The percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods.</description>
        <time_frame>The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dynamic Arm</title>
            <description>This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.</description>
          </group>
          <group group_id="O2">
            <title>Static Arm</title>
            <description>This arm includes the study participants that participated in static image acquisition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device</title>
          <description>The percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.67"/>
                    <measurement group_id="O2" value="23.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The time frame would be from the time the sensors were placed to the time it took the subjects to respond to questions; no more than 2 hours.</time_frame>
      <desc>Adverse events were collected during study participation. Participants completed a short questionnaire after participation to rate the pain of the sensor pads, pain of sensor placement, pain of sensor wires, and pain of removal of pads from skin.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dynamic Arm</title>
          <description>This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.</description>
        </group>
        <group group_id="E2">
          <title>Static Arm</title>
          <description>This arm includes the study participants that participated in static image acquisition.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations: How the reading physicians visually assessed the radioactivity presence at the injection site may not consistently compare to the quantitative TACs. The motion of the patient during sensor measurement may affect measurements.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Medhat Osman, MD, PhD - Professor of Radiology, Director of Nuclear Medicine and PET/CT</name_or_title>
      <organization>Saint Louis University</organization>
      <phone>314-577-8047</phone>
      <email>medhat.osman@health.slu.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041090
org study id: SLU IRB # 26741
nct id: NCT03041090
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
PET (Positron Emission Tomography) images are used to help make patient management decisions
      in staging and treatment assessment, often after a cancer diagnosis.

      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is
      known as extravasation or infiltration, and it compromises the doctor's ability to read the
      PET image. Often, the site where the tracer is injected into the vein (usually in the inside
      of the elbow) are not in the images taken, so reading physicians are unaware that an
      extravasation or infiltration has occurred.

      Technology exists to capture time activity curves (amount of tracer in a location over a
      period of time) during the PET tracer uptake period (usually once the tracer is injected, the
      tracer circulates for 60 minutes prior to images), which can enable physicians to accurately
      detect extravasations and infiltration. This information is currently unavailable to
      physicians reading routine PET/CT (computed tomography) scans.

      Time activity curves information gathered from these sensors during the circulation period
      appear to match the brief pictures taken approximately 70 minutes after the tracer injection.

      This study will determine if these time activity curves correspond to PET images of the
      injection site taken during the tracer uptake period. If time activity curves correspond to
      PET images, they can be used to determine if the tracer was properly injected. If there was
      an improper injection, clinicians can be alerted to this fact and interpret the image with
      this additional information.
PET (Positron Emission Tomography) images are used to help make patient management decisions
      in staging and treatment assessment, often after a cancer diagnosis.

      Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is
      known as extravasation or infiltration, and it compromises the doctor's ability to read the
      PET image. Often, the site where the tracer is injected into the vein (usually in the inside
      of the elbow) are not in the images taken, so reading physicians are unaware that an
      extravasation or infiltration has occurred.

      Technology exists to capture time activity curves (amount of tracer in a location over a
      period of time) during the PET tracer uptake period (usually once the tracer is injected, the
      tracer circulates for 60 minutes prior to images), which can enable physicians to accurately
      detect extravasations. This information is currently unavailable to physicians reading
      routine PET/CT scans.

      Time activity curves information gathered from these sensors during the circulation period
      appear to match the brief pictures taken approximately 70 minutes after the tracer injection.

      This study will determine if these time activity curves correspond to PET images of the
      injection site taken during the tracer uptake period. If time activity curves correspond to
      PET images, they can be used to determine if the tracer was properly injected. If there was
      an improper injection, clinicians can be alerted to this fact and interpret the image with
      this additional information.

      In oncology, whole-body PET/CT is typically performed from the head to the pelvic floor (eyes
      to thighs). The use of the term whole-body is misleading because the most commonly used field
      of view (FOV) for arms-up whole-body PET/CT protocols includes only the base of skull to the
      upper thighs and does not include the brain, skull, and large portions of both upper and
      lower extremities. In such FOV, the most commonly used site of injection, namely the
      antecubital fossa (inside of the elbow), is frequently not included in the imaging field. In
      the Frontiers in Oncology article, Osman also determined that based on the commonly used FOV
      at most PET/CT centers, that when infiltration is present, it may be unnoticed by clinicians
      in approximately 31% of the cases.

      Lucerno Dynamics, a privately held company in North Carolina, has also discovered that the
      static image may be incapable of reporting on the quality of FDG administration during the
      ~60 minute uptake period. Lucerno's system has been used in two investigational studies at
      two centers. At one center, the system was used with 8 patients for a total of 15 scans. At
      the other center, the system was used with 40 patients for a total of 85 scans. Similar rates
      of infiltrations were found to those described in the published articles. Based on this
      experience, Lucerno has found that infiltrations can partially resolve during the uptake
      period, so that even if they are visible in the PET image, the image may not reveal the
      extent of the infiltration. This could severely and negatively impact research and therapy
      decisions and thus patient outcomes.

      The Lucerno devices (Lucerno ID) are nonsignificant risk devices that add only 2-3 minutes to
      the current standard of care PET/CT scanning process. Lucerno ID sensors are applied to the
      patient's skin before the injection of the radiotracer and are removed after the FDG uptake
      period and prior to the PET/CT imaging process. The Lucerno ID has the ability to identify
      infiltrations, whether they are within or outside the FOV of reviewing clinicians, and can
      alert clinicians before their patient undergoes a compromised PET/CT scan due to the
      infiltration. This technology can prevent patients from receiving the additional CT radiation
      exposure of a compromised scan, can save cost, and can improve patient outcomes by ensuring
      more accurate PET scan interpretation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All participants are included in the static imaging arm. Some participants were also included in the dynamic imaging arm
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians
time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
description: Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.
measure: Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration
time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
description: Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site.
measure: Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device
time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
description: The percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods.
arm group label: Static Imaging participants
arm group type: Experimental
description: This arm of the study assessed participants' static PET/CT images. These were the standard of care images acquired after their standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.
Intervention was Lucerno sensors (Lucerno Device Identity Document (LD ID), Lucerno Device 1 (LD1), Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.
arm group label: Dynamic image participants
arm group type: Experimental
description: This arm of the study assessed participants' dynamic PET/CT images. These were the study related images of and around the injection site acquired during the participants' standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.
Intervention was Lucerno sensors (LD ID, LD1, Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.
intervention type: Device
intervention name: Lucerno ID (identification) System
description: The Lucerno ID is intended to dynamically measure the uptake of radiotracer in a particular organ or body region during the radiotracer uptake period as part of nuclear medicine (NM) procedures. The Lucerno ID is indicated for use as a tool for trained healthcare professionals (technologists, NM physicians, and radiologists) to help assess whether a radiotracer injection has resulted in an infiltration. The LD ID can be used by healthcare professionals including nuclear medical technologists, nuclear medicine physicians, or any other medical staff in a NM facility, once they have received the necessary training into the use of the system.
arm group label: Dynamic image participants
arm group label: Static Imaging participants
other name: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/29127247
description: Published article: Novel Method to Detect and Characterize 18Fluoride-FDG Infiltration at the Injection Site: A Single-Institution Experience
url: https://www.ncbi.nlm.nih.gov/pubmed/29042469
description: Published article: The Importance of Quality Control for Clinical PET Imaging
citation: Muzaffar R, Frye SA, McMunn A, Ryan K, Lattanze R, Osman MM. Novel Method to Detect and Characterize 18F-FDG Infiltration at the Injection Site: A Single-Institution Experience. J Nucl Med Technol. 2017 Dec;45(4):267-271. doi: 10.2967/jnmt.117.198408. Epub 2017 Nov 10.
PMID: 29127247
citation: Schaefferkoetter JD, Osman M, Townsend DW. The Importance of Quality Control for Clinical PET Imaging. J Nucl Med Technol. 2017 Dec;45(4):265-266. doi: 10.2967/jnmt.117.198465. Epub 2017 Oct 17. No abstract available.
PMID: 29042469
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Medhat M. Osman, MD., Sc.M., Ph.D.
investigator title: Professor of Radiology; Director of Nuclear Medicine & PET/CT
sharing ipd: Yes
ipd description: Coded data will be shared with our industry sponsor, Lucerno Dynamics
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations: How the reading physicians visually assessed the radioactivity presence at the injection site may not consistently compare to the quantitative TACs. The motion of the patient during sensor measurement may affect measurements.
point of contact: 