xml: <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/NCT05996432</url>
    </required_header>
    <id_info>
      <org_study_id>VICC-EDMDT23195</org_study_id>
      <nct_id>NCT05996432</nct_id>
    </id_info>
    <brief_title>Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy</brief_title>
    <official_title>Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vanderbilt-Ingram Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Vanderbilt-Ingram Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will apply novel MRI approaches with established sensitivity to tissue oxygen&#xD;
        consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as&#xD;
        tumor recurrence and progression post-treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
        - To validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain&#xD;
        metastases or head and neck cancer with and without evidence of tumor hypoxia identified by&#xD;
        18F-FMISO-PET-CT.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  To assess treatment-related changes in tumor and peritumoral tissue oxygen consumption&#xD;
             and perfusion via non-invasive MRI.&#xD;
  &#xD;
          -  To evaluate the effect of pre-treatment and post-treatment (3 months) tumor hypoxia on&#xD;
             tumor recurrence, progression, and radiation necrosis in patients with central nervous&#xD;
             system metastases treated with standard of care stereotactic radiosurgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 17, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2026</primary_completion_date>
    <phase>Early Phase 1</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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT</measure>
      <time_frame>1.5 years</time_frame>
      <description>MRI assessed oxygen extraction fraction (OEF, %)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI</measure>
      <time_frame>4 years</time_frame>
      <description>MRI assessed oxygen extraction fraction (OEF, %)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome</measure>
      <time_frame>4 years</time_frame>
      <description>Tumor recurrence</description>
    </other_outcome>
    <other_outcome>
      <measure>Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome</measure>
      <time_frame>4 years</time_frame>
      <description>Radiation necrosis</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Head and Neck Squamous Cell Carcinoma</condition>
    <condition>Brain Metastases</condition>
    <arm_group>
      <arm_group_label>Locally Advanced Squamous Cell Carcinoma of the Head and Neck</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Brain metastases</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
      <description>Participants will undergo Magnetic Resonance Imaging</description>
      <arm_group_label>Brain metastases</arm_group_label>
      <arm_group_label>Locally Advanced Squamous Cell Carcinoma of the Head and Neck</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Positron Emission Tomography (PET)</intervention_name>
      <description>Participants will undergo Positron Emission Tomography</description>
      <arm_group_label>Brain metastases</arm_group_label>
      <arm_group_label>Locally Advanced Squamous Cell Carcinoma of the Head and Neck</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>18F-fluoromisonidazole</intervention_name>
      <description>Given by IV</description>
      <arm_group_label>Brain metastases</arm_group_label>
      <arm_group_label>Locally Advanced Squamous Cell Carcinoma of the Head and Neck</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically or cytologically confirmed head and neck squamous cell carcinoma or a&#xD;
               clinical diagnosis of CNS-excluded nervous system neoplasm and disorder (brain&#xD;
               metastases)&#xD;
  &#xD;
            -  Measurable disease, defined as at least one lesion that can be accurately measured in&#xD;
               at least one dimension (longest diameter to be recorded for non-nodal lesions and&#xD;
               short axis for nodal lesions, minimum size 7mm) with CT scan, MRI, or calipers by&#xD;
               clinical exam&#xD;
  &#xD;
            -  ECOG performance status &lt;/=1 Karnofsky &gt;/=70%&#xD;
  &#xD;
            -  Life expectancy of greater than 6 months&#xD;
  &#xD;
            -  The effects of 18F-FMISO on the developing human fetus are unknown. For this reason,&#xD;
               women of child-bearing potential and men must agree to use adequate contraception&#xD;
               (hormonal or barrier method of birth control; abstinence) prior to study entry and up&#xD;
               until the day after 18F-FMISO administration. Should a woman become pregnant or&#xD;
               suspect she is pregnant while she or her partner is participating in this study, she&#xD;
               should inform her treating physician immediately. Men treated or enrolled on this&#xD;
               protocol must also agree to use adequate contraception on the days of 18F-FMISO&#xD;
               administration&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to 18F-FMISO&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
               infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
               arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  Brain metastases &gt;3.0 cm&#xD;
  &#xD;
            -  Dural-based metastases concerning for leptomeningeal disease&#xD;
  &#xD;
            -  Hemorrhage within the lesion of interest&#xD;
  &#xD;
            -  Patients presenting for radiation after surgical resection of brain&#xD;
               metastasis/metastases or primary head and neck cancer (adjuvant radiotherapy)&#xD;
  &#xD;
            -  Prior or current known history of disease involving the brain other than brain&#xD;
               metastases and including but not limited to; cerebrovascular disease (i.e., stroke or&#xD;
               large vessel disease), brain hemorrhage (i.e., subarachnoid hemorrhage or&#xD;
               intraparenchymal hemorrhage), Alzheimer's disease or dementia, Parkinson's disease,&#xD;
               Multiple Sclerosis or schizophrenia&#xD;
  &#xD;
            -  Prior overlapping radiation fields&#xD;
  &#xD;
            -  Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic&#xD;
               objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips,&#xD;
               surgical clips, prostheses, artificial hearts, valves with steel parts, metal&#xD;
               fragments, shrapnel, tattoos near the imaging site, or steel implants)&#xD;
  &#xD;
            -  Presence of any other co-existing condition which, in the judgment of the&#xD;
               investigator, might increase the risk to the subject&#xD;
  &#xD;
            -  Presence of serious systemic illness, including uncontrolled intercurrent infection or&#xD;
               psychiatric/social situations which may limit compliance with study requirements&#xD;
  &#xD;
            -  Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit&#xD;
               for the MRI table)&#xD;
  &#xD;
            -  Prisoners, children &lt;18 years of age&#xD;
  &#xD;
            -  Prior overlapping radiation fields&#xD;
  &#xD;
            -  Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic&#xD;
               objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips,&#xD;
               surgical clips, prostheses, artificial hearts, valves with steel parts, metal&#xD;
               fragments, shrapnel, tattoos near the imaging site, or steel implants)&#xD;
  &#xD;
            -  Presence of any other co-existing condition which, in the judgment of the&#xD;
               investigator, might increase the risk to the subject&#xD;
  &#xD;
            -  Presence of serious systemic illness, including uncontrolled intercurrent infection or&#xD;
               psychiatric/social situations which may limit compliance with study requirements&#xD;
  &#xD;
            -  Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit&#xD;
               for the MRI table)&#xD;
  &#xD;
            -  Prisoners, children &lt;18 years of age&#xD;
  &#xD;
            -  The effects of 18F-FMISO on the developing infant are unknown. For this reason,&#xD;
               nursing women will be excluded from the trial&#xD;
  &#xD;
          Pregnant patients which will be identified as follows;&#xD;
  &#xD;
            -  Patients over the age of 60 do not require a pregnancy test per institutional&#xD;
               guidelines. We anticipate this to be most of our patient population due to the age&#xD;
               distribution of cancer patients.&#xD;
  &#xD;
            -  Patients under the age of 60 will be offered a point of care pregnancy test when seen&#xD;
               in consult at the department of Radiation Oncology.&#xD;
  &#xD;
            -  Patients refusing pregnancy testing can sign a waiver stating that they refuse&#xD;
               pregnancy testing but that they are not known to be pregnant&#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>Jill De Vis, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vanderbilt University/Ingram Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vanderbilt-Ingram Services for Timely Access</last_name>
      <phone>800-811-8480</phone>
      <email>cip@vumc.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Vanderbilt University/Ingram Cancer Center</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vanderbilt-Ingram Service Services for Timely Access</last_name>
        <phone>800-811-8480</phone>
        <email>cip@vumc.org</email>
      </contact>
      <investigator>
        <last_name>Jill De Vis, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
      <investigator_full_name>Jill De Vis</investigator_full_name>
      <investigator_title>Assistant Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Neoplasms</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996432
  org study id: VICC-EDMDT23195
  nct id: NCT05996432
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will apply novel MRI approaches with established sensitivity to tissue oxygen
        consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as
        tumor recurrence and progression post-treatment.
  Primary Objective:
  
        - To validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain
        metastases or head and neck cancer with and without evidence of tumor hypoxia identified by
        18F-FMISO-PET-CT.
  
        Secondary Objectives:
  
          -  To assess treatment-related changes in tumor and peritumoral tissue oxygen consumption
             and perfusion via non-invasive MRI.
  
          -  To evaluate the effect of pre-treatment and post-treatment (3 months) tumor hypoxia on
             tumor recurrence, progression, and radiation necrosis in patients with central nervous
             system metastases treated with standard of care stereotactic radiosurgery.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT
  time frame: 1.5 years
  description: MRI assessed oxygen extraction fraction (OEF, %)
  measure: Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI
  time frame: 4 years
  description: MRI assessed oxygen extraction fraction (OEF, %)
  measure: Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome
  time frame: 4 years
  description: Tumor recurrence
  measure: Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome
  time frame: 4 years
  description: Radiation necrosis
  arm group label: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
  arm group type: Experimental
  description: Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
  arm group label: Brain metastases
  arm group type: Experimental
  description: Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
  intervention type: Procedure
  intervention name: Magnetic Resonance Imaging (MRI)
  description: Participants will undergo Magnetic Resonance Imaging
  arm group label: Brain metastases
  arm group label: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
  intervention type: Procedure
  intervention name: Positron Emission Tomography (PET)
  description: Participants will undergo Positron Emission Tomography
  arm group label: Brain metastases
  arm group label: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
  intervention type: Drug
  intervention name: 18F-fluoromisonidazole
  description: Given by IV
  arm group label: Brain metastases
  arm group label: Locally Advanced Squamous Cell Carcinoma of the Head and Neck
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jill De Vis, MD, PhD
  role: Principal Investigator
  affiliation: Vanderbilt University/Ingram Cancer Center
  last name: Vanderbilt-Ingram Services for Timely Access
  phone: 800-811-8480
  email: cip@vumc.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Vanderbilt-Ingram Cancer Center
  investigator full name: Jill De Vis
  investigator title: Assistant Professor of Medicine
  mesh term: Brain Neoplasms
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Hypoxia
  sharing ipd: Undecided