<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/NCT03307564</url>
  </required_header>
  <id_info>
    <org_study_id>J17144</org_study_id>
    <secondary_id>IRB00151816</secondary_id>
    <nct_id>NCT03307564</nct_id>
  </id_info>
  <brief_title>Radiopaque Hydrogel in Patients Undergoing Radiotherapy for Pancreatic Cancer</brief_title>
  <official_title>Evaluation of a Novel Absorbable Radiopaque Hydrogel in Patients Undergoing Image-guided Radiotherapy for Pancreatic Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Augmenix, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this pilot imaging study is to evaluate the visibility of marking the interface&#xD;
      between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically&#xD;
      confirmed diagnosis of BR/LAPC (borderline resectable/locally advanced pancreatic cancer)&#xD;
      pancreatic adenocarcinomas indicated for neo-adjuvant image-guided radiotherapy with SBRT&#xD;
      (stereotactic body radiation therapy) will be enrolled. This study will thus set the stage&#xD;
      for further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with&#xD;
      imaging localization, enabling further dose intensification with SBRT or IMRT to improve the&#xD;
      clinical outcomes in BR/LAPC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic ductal adenocarcinoma is now the third leading cause of cancer-related death, with&#xD;
      a devastating 5-year overall survival (OS) rate of nearly 8%, despite having the 12th most&#xD;
      common incidence of all malignancies in the United States. One-third of patients will present&#xD;
      with borderline resectable or unresectable, locally advanced pancreatic cancer (BR/LAPC). In&#xD;
      the cases of LAPC, chemotherapy with or without radiation may be recommended to improve the&#xD;
      quality of life by relieving symptoms and extending survival. Despite aggressive combined&#xD;
      modality therapy, the median survival remains between 9 and 15 months.&#xD;
&#xD;
      Current guidelines for the management of BR/LAPC patients include single- or multi-agent&#xD;
      chemotherapy or chemoradiation (CRT) in sequence with chemotherapy. Results of studies&#xD;
      comparing chemotherapy alone to CRT for patients with BR/LAPC are mixed. The importance of&#xD;
      local control or delaying local progression on improving morbidity and possibly mortality in&#xD;
      patients with pancreatic cancer is supported by autopsy data demonstrating that 30% of&#xD;
      patients die of locally destructive disease. It follows that in the cases of LAPC, advanced&#xD;
      radiation therapy techniques using dose-escalation with intensity modulated radiotherapy&#xD;
      (IMRT) and stereotactic body radiotherapy (SBRT) are potential strategies to improve local&#xD;
      control.&#xD;
&#xD;
      A consistent challenge to dose-escalation with IMRT (intensity modulation radiation therapy)&#xD;
      or SBRT is the sensitivity of the surrounding gastrointestinal organs, particularly the small&#xD;
      bowel which is directly adjacent to the head of the pancreas head of the pancreas (HOP). For&#xD;
      BR/LAPC patients treated with CRT, advances in image guidance have provided the opportunity&#xD;
      to safely deliver higher biologically effective doses of radiation therapy using IMRT of &gt;70&#xD;
      Gy (57.25 Gy in 25 fractions, BED 70.36 Gy) compared to standard fractionation regimens&#xD;
      (50.40 Gy in 28 fractions or 50 Gy in 25 fractions, BED 59.47 Gy and 60 Gy, respectively).&#xD;
      Those patients who underwent dose-escalated CRT with BED&gt;70 Gy, did have a superior OS&#xD;
      compared to those receiving BED&lt;70 Gy, supporting the utility of dose-escalation in improving&#xD;
      long-term outcomes. SBRT involves a short course of radiation therapy, five fractions or&#xD;
      less, and has demonstrated higher rates of local control compared to CRT in other disease&#xD;
      sites. Early studies evaluating SBRT for pancreatic cancer utilized single fractions of 25&#xD;
      Gy, resulting in local control rates of 100% at 1 year but unacceptably high rates of&#xD;
      gastrointestinal toxicity. More recently, hypofractionated SBRT (33 Gy total, 6.6 Gy daily&#xD;
      fractions) has been evaluated and utilized by our group in an effort to reduce the toxicity&#xD;
      of therapy, with results demonstrating nearly 80% rate of freedom from local progression at&#xD;
      one year and an acceptable 11% long-term gastrointestinal toxicity. Outcomes with SBRT are&#xD;
      thus promising; however, higher local control rates with dose-escalation may be achievable,&#xD;
      but current practice is limited due to risks of toxicity.&#xD;
&#xD;
      The goal of this pilot imaging study is to evaluate the visibility of marking the interface&#xD;
      between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically&#xD;
      confirmed diagnosis of BR/LAPC pancreatic adenocarcinomas indicated for neo-adjuvant&#xD;
      image-guided radiotherapy with SBRT will be enrolled. This study will thus set the stage for&#xD;
      further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with&#xD;
      imaging localization, enabling further dose intensification with SBRT or IMRT to improve the&#xD;
      clinical outcomes in BR/LAPC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients Where TraceIT Tissue Marker Placement Achieved</measure>
    <time_frame>day 1</time_frame>
    <description>Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>TraceIT tissue marker injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TraceIT tissue marker injection</intervention_name>
    <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.</description>
    <arm_group_label>TraceIT tissue marker injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years old&#xD;
&#xD;
          2. BR/LAPC pancreatic carcinoma disease&#xD;
&#xD;
          3. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated with the&#xD;
             intent for eventual surgical resection&#xD;
&#xD;
          4. Subjects Screening/Baseline laboratory testing must meet the following laboratory&#xD;
             value criteria:&#xD;
&#xD;
               1. White blood cell count: ≥ 3.0 x 109/L&#xD;
&#xD;
               2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L&#xD;
&#xD;
               3. Platelets: ≥ 100 x 109/L&#xD;
&#xD;
               4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)&#xD;
&#xD;
               5. AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase): ≤ 3.0 times&#xD;
                  institutional upper normal limit&#xD;
&#xD;
               6. Serum creatinine: 1.5 times ULN (upper limit of normal)&#xD;
&#xD;
               7. INR (international normalized ratio): &lt; 1.5&#xD;
&#xD;
               8. Serum pregnancy: Negative&#xD;
&#xD;
               9. Hemoglobin: ≥ 8.0 g/dl&#xD;
&#xD;
          5. Zubrod Performance Status 0-2&#xD;
&#xD;
          6. Subject or authorized representative, has been informed of the nature of the study and&#xD;
             has provided written informed consent, approved by the appropriate Institutional&#xD;
             Review Board (IRB) of the respective clinical site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous thoracic radiotherapy&#xD;
&#xD;
          2. Any GI (gastrointestinal) abnormality that would interfere with the ability to access&#xD;
             the injection site&#xD;
&#xD;
          3. Active gastroduodenal ulcer or watery diarrhea&#xD;
&#xD;
          4. Active bleeding disorder or a clinically significant coagulopathy defined as a PTT&#xD;
             (Partial thromboplastin time) &gt;35s or INR&gt;1.4 or platelet count less than 100,000 per&#xD;
             mm3.&#xD;
&#xD;
          5. Active inflammatory or infectious process involving the gastrointestinal tract based&#xD;
             on positive diagnosis or suspected diagnosis in the presence of fever&gt;38°C or&#xD;
             WBC&gt;12,000/uL.&#xD;
&#xD;
          6. Compromised immune system: WBC (white blood count) &lt;4000/uL or &gt;12,000/uL.&#xD;
&#xD;
          7. History of Chronic Renal Failure.&#xD;
&#xD;
          8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that&#xD;
             cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or&#xD;
             frequent swings between hyperglycemia and hypoglycemia)&#xD;
&#xD;
          9. Currently enrolled in another investigational drug or device trial that clinically&#xD;
             interferes with this study.&#xD;
&#xD;
         10. Unable to comply with the study requirements or follow-up schedule.&#xD;
&#xD;
         11. Any condition or comorbidity that the Investigator believes would interfere with the&#xD;
             intent of the study or would make participation not in the best interest of the&#xD;
             subject.&#xD;
&#xD;
         12. Pregnancy, breast-feeding, women of child-bearing age must use contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amol Narang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins SKCCC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231-2410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <results_first_submitted>October 31, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2022</results_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03307564/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TraceIT Tissue Marker Injection</title>
          <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments&#xD;
TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TraceIT Tissue Marker Injection</title>
          <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments&#xD;
TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>white/caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Where TraceIT Tissue Marker Placement Achieved</title>
        <description>Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.</description>
        <time_frame>day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TraceIT Tissue Marker Injection</title>
            <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments&#xD;
TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Where TraceIT Tissue Marker Placement Achieved</title>
          <description>Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>immediate post-procedure period (approximately 3 hours after injection of hydrogel while patients in recovery/observation)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>TraceIT Tissue Marker Injection</title>
          <description>The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments&#xD;
TraceIT tissue marker injection: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <description>Grade 3</description>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="6"/>
              </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="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Amol Narang. MD</name_or_title>
      <organization>SKCCC @ Johns Hopkins</organization>
      <phone>410-955-7390</phone>
      <email>anarang2@jhmi.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/NCT03307564
org study id: J17144
secondary id: IRB00151816
nct id: NCT03307564
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The goal of this pilot imaging study is to evaluate the visibility of marking the interface
      between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically
      confirmed diagnosis of BR/LAPC (borderline resectable/locally advanced pancreatic cancer)
      pancreatic adenocarcinomas indicated for neo-adjuvant image-guided radiotherapy with SBRT
      (stereotactic body radiation therapy) will be enrolled. This study will thus set the stage
      for further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with
      imaging localization, enabling further dose intensification with SBRT or IMRT to improve the
      clinical outcomes in BR/LAPC.
Pancreatic ductal adenocarcinoma is now the third leading cause of cancer-related death, with
      a devastating 5-year overall survival (OS) rate of nearly 8%, despite having the 12th most
      common incidence of all malignancies in the United States. One-third of patients will present
      with borderline resectable or unresectable, locally advanced pancreatic cancer (BR/LAPC). In
      the cases of LAPC, chemotherapy with or without radiation may be recommended to improve the
      quality of life by relieving symptoms and extending survival. Despite aggressive combined
      modality therapy, the median survival remains between 9 and 15 months.

      Current guidelines for the management of BR/LAPC patients include single- or multi-agent
      chemotherapy or chemoradiation (CRT) in sequence with chemotherapy. Results of studies
      comparing chemotherapy alone to CRT for patients with BR/LAPC are mixed. The importance of
      local control or delaying local progression on improving morbidity and possibly mortality in
      patients with pancreatic cancer is supported by autopsy data demonstrating that 30% of
      patients die of locally destructive disease. It follows that in the cases of LAPC, advanced
      radiation therapy techniques using dose-escalation with intensity modulated radiotherapy
      (IMRT) and stereotactic body radiotherapy (SBRT) are potential strategies to improve local
      control.

      A consistent challenge to dose-escalation with IMRT (intensity modulation radiation therapy)
      or SBRT is the sensitivity of the surrounding gastrointestinal organs, particularly the small
      bowel which is directly adjacent to the head of the pancreas head of the pancreas (HOP). For
      BR/LAPC patients treated with CRT, advances in image guidance have provided the opportunity
      to safely deliver higher biologically effective doses of radiation therapy using IMRT of >70
      Gy (57.25 Gy in 25 fractions, BED 70.36 Gy) compared to standard fractionation regimens
      (50.40 Gy in 28 fractions or 50 Gy in 25 fractions, BED 59.47 Gy and 60 Gy, respectively).
      Those patients who underwent dose-escalated CRT with BED>70 Gy, did have a superior OS
      compared to those receiving BED<70 Gy, supporting the utility of dose-escalation in improving
      long-term outcomes. SBRT involves a short course of radiation therapy, five fractions or
      less, and has demonstrated higher rates of local control compared to CRT in other disease
      sites. Early studies evaluating SBRT for pancreatic cancer utilized single fractions of 25
      Gy, resulting in local control rates of 100% at 1 year but unacceptably high rates of
      gastrointestinal toxicity. More recently, hypofractionated SBRT (33 Gy total, 6.6 Gy daily
      fractions) has been evaluated and utilized by our group in an effort to reduce the toxicity
      of therapy, with results demonstrating nearly 80% rate of freedom from local progression at
      one year and an acceptable 11% long-term gastrointestinal toxicity. Outcomes with SBRT are
      thus promising; however, higher local control rates with dose-escalation may be achievable,
      but current practice is limited due to risks of toxicity.

      The goal of this pilot imaging study is to evaluate the visibility of marking the interface
      between the pancreas and duodenum with TraceIT Tissue Marker. Patients with a pathologically
      confirmed diagnosis of BR/LAPC pancreatic adenocarcinomas indicated for neo-adjuvant
      image-guided radiotherapy with SBRT will be enrolled. This study will thus set the stage for
      further investigations using the TraceIT Tissue Marker to avoid duodenum toxicity with
      imaging localization, enabling further dose intensification with SBRT or IMRT to improve the
      clinical outcomes in BR/LAPC.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients Where TraceIT Tissue Marker Placement Achieved
time frame: day 1
description: Measured as number of patients where marking the interface between the pancreas and duodenum with TraceIT Tissue Marker in patients undergoing image-guided radiotherapy for BR/LAPC pancreatic adenocarcinoma was achieved.
arm group label: TraceIT tissue marker injection
arm group type: Experimental
description: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments
intervention type: Device
intervention name: TraceIT tissue marker injection
description: The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
arm group label: TraceIT tissue marker injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Amol Narang, MD
role: Principal Investigator
affiliation: Johns Hopkins SKCCC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 