<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/NCT03286972</url>
  </required_header>
  <id_info>
    <org_study_id>UW16064</org_study_id>
    <secondary_id>2017-0162</secondary_id>
    <secondary_id>A533300</secondary_id>
    <secondary_id>SMPH\HUMAN ONCOLOGY\HUMAN ONCO</secondary_id>
    <secondary_id>NCI-2019-05974</secondary_id>
    <nct_id>NCT03286972</nct_id>
  </id_info>
  <brief_title>PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning</brief_title>
  <official_title>PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate this new technology available at the University of&#xD;
      Wisconsin Carbone Cancer Center in the setting of head and neck cancer radiation treatment&#xD;
      planning. This study will also provide preliminary data critical to the development of&#xD;
      multi-parametric, multi-modality quantitative imaging biomarkers and data analysis models for&#xD;
      prediction of outcome in both tumors and normal tissue, which are essential for&#xD;
      patient-specific adaptive therapy.&#xD;
&#xD;
      All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per&#xD;
      SOC procedures. In addition, all participants will undergo an additional imaging set&#xD;
      consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the&#xD;
      same day as their PET/CT negating the need for a second injection of the FDG radioisotope&#xD;
      used for SOC PET imaging. All patients will receive gadolinium contrast per SOC dosing&#xD;
      guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and&#xD;
      investigational sequences will be utilized in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants able to complete the PET/MRI examination</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Identify the percentage of head and neck cancer patients who are able to successfully complete or partially complete the PET/MRI examination. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in staging between PET/CT and PET/MRI</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Compare changes in tumor and regional staging between PET/CT and PET/MRI. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PET/MRI in radiation treatment planning workflow</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of image quality and image fusion of PET/MRI data with the treatment planning CT, as compared to PET/CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Pulse sequences will be assess with Wilcoxon signed rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Differences in simulated radiation treatment planning volumes will be assess with Wilcoxon signed rank test.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>PET/MRI</arm_group_label>
    <description>All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per SOC procedures. In addition, all participants will undergo an additional imaging set consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the same day as their PET/CT negating the need for a second injection of the FDG radioisotope used for SOC PET imaging. All participants will receive gadolinium contrast per SOC dosing guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and investigational sequences will be utilized in this study.&#xD;
If a second dose of the radioisotope is need to complete the PET/MRI (unable to perform both PET scans on the same day) only a 50% dose of FDG will be administered due to the increased sensitivity the PET/MRI scanner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>Participants will be placed in standard non-ferrous head and neck immobilization devices during PET/MRI (to simulate their anticipated positioning during subsequent CT simulation and treatment). A head/neck PET/MRI (standard bore size, 60 cm) will be performed</description>
    <arm_group_label>PET/MRI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The planned enrollment of 40 participants includes 4-12 patients in each of the 5 anatomic&#xD;
        subgroups. This will allow flexibility in enrollment to reflect the frequency pattern of&#xD;
        case presentation and any early findings that may suggest one or more sub-sites are&#xD;
        particularly well suited to disclose valuable tumor data using PET/MRI scans.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with tumors of the head and neck region (nasal cavity, oral cavity,&#xD;
             pharynx, larynx, sinuses, salivary glands, and head and neck skin) who are candidates&#xD;
             for radiation treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI: All patients will be screened with standard UWHC MRI&#xD;
             screening procedures:&#xD;
&#xD;
          -  Any person with the following will be excluded: cardiac pacemaker, metal fragments in&#xD;
             or around the eye, venous umbrella, permanent eyeliner or permanent artificial&#xD;
             eyebrows.&#xD;
&#xD;
        Patents with the following potentially non-MRI compatible devices will undergo screening&#xD;
        using the standard UWHC MRI screening protocol by trained UWHC personnel: cardiac&#xD;
        pacemaker, heart valve replacement, intracranial aneurysm clips, middle ear, eye, joint, or&#xD;
        penile implants, joint replacements, implantable hearing aids, neurostimulator devices,&#xD;
        insulin pumps, shunts/stents, metal mesh/coil implants; metal plate/pin/screws/wires, or&#xD;
        any other metallic implants. Also patients with anatomical constraints limiting the&#xD;
        feasibility of MRI will be excluded.&#xD;
&#xD;
        - Issue of pregnancy: We will exclude all known pregnant females from the study to avoid&#xD;
        the potential risk of fetal injury upon exposure to the PET scan. Determination of&#xD;
        pregnancy will be based upon the standard screening procedures in place for radiation&#xD;
        therapy.&#xD;
&#xD;
          -  Persons who are not fluent in English&#xD;
&#xD;
          -  Anyone who can not provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul M Harari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.uwhealth.org/uw-carbone-cancer-center/47424</url>
    <description>UW Carbone Cancer Center home page</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03286972
org study id: UW16064
secondary id: 2017-0162
secondary id: A533300
secondary id: SMPH\HUMAN ONCOLOGY\HUMAN ONCO
secondary id: NCI-2019-05974
nct id: NCT03286972
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate this new technology available at the University of
      Wisconsin Carbone Cancer Center in the setting of head and neck cancer radiation treatment
      planning. This study will also provide preliminary data critical to the development of
      multi-parametric, multi-modality quantitative imaging biomarkers and data analysis models for
      prediction of outcome in both tumors and normal tissue, which are essential for
      patient-specific adaptive therapy.

      All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per
      SOC procedures. In addition, all participants will undergo an additional imaging set
      consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the
      same day as their PET/CT negating the need for a second injection of the FDG radioisotope
      used for SOC PET imaging. All patients will receive gadolinium contrast per SOC dosing
      guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and
      investigational sequences will be utilized in this study.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of participants able to complete the PET/MRI examination
time frame: Up to 1 year
description: Identify the percentage of head and neck cancer patients who are able to successfully complete or partially complete the PET/MRI examination. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.
measure: Changes in staging between PET/CT and PET/MRI
time frame: Up to 1 year
description: Compare changes in tumor and regional staging between PET/CT and PET/MRI. Responses to a 7 point Likert scale will be analyzed with a chi-squared test.
measure: Feasibility of PET/MRI in radiation treatment planning workflow
time frame: Up to 1 year
description: Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of image quality and image fusion of PET/MRI data with the treatment planning CT, as compared to PET/CT.
measure: Compare conventional MRI pulse sequences to investigational MRI pulse sequences for tumor conspicuity and image quality
time frame: Up to 1 year
description: Pulse sequences will be assess with Wilcoxon signed rank test.
measure: Compare changes in simulated radiation treatment volume when derived from PET/MRI vs PET/CT (GTV, CTV, PTV)
time frame: Up to 1 year
description: Differences in simulated radiation treatment planning volumes will be assess with Wilcoxon signed rank test.
arm group label: PET/MRI
description: All participants will undergo a diagnostic PET/CT and a Radiation Treatment Planning CT per SOC procedures. In addition, all participants will undergo an additional imaging set consisting of a PET/MRI. It is anticipated that most patients will undergo the PET/MRI on the same day as their PET/CT negating the need for a second injection of the FDG radioisotope used for SOC PET imaging. All participants will receive gadolinium contrast per SOC dosing guidelines for the MRI portion of the PET/MRI. Both SOC MMRI pulse sequences and investigational sequences will be utilized in this study.
If a second dose of the radioisotope is need to complete the PET/MRI (unable to perform both PET scans on the same day) only a 50% dose of FDG will be administered due to the increased sensitivity the PET/MRI scanner.
intervention type: Device
intervention name: PET/MRI
description: Participants will be placed in standard non-ferrous head and neck immobilization devices during PET/MRI (to simulate their anticipated positioning during subsequent CT simulation and treatment). A head/neck PET/MRI (standard bore size, 60 cm) will be performed
arm group label: PET/MRI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul M Harari, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: http://www.uwhealth.org/uw-carbone-cancer-center/47424
description: UW Carbone Cancer Center home page
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms