<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/NCT02233595</url>
  </required_header>
  <id_info>
    <org_study_id>144513</org_study_id>
    <secondary_id>NCI-2015-00980</secondary_id>
    <nct_id>NCT02233595</nct_id>
  </id_info>
  <brief_title>Evaluation of Rectal Cancer Treatment Response Using PET/MRI</brief_title>
  <acronym>Rectal PET/MRI</acronym>
  <official_title>Evaluation of Rectal Cancer Treatment Response Using PET/MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will be using the combination of FDG-PET and multiparametric MRI in pre-&#xD;
      and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response&#xD;
      on surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low Accrual&#xD;
  </why_stopped>
  <start_date type="Actual">October 15, 2014</start_date>
  <completion_date type="Actual">January 28, 2018</completion_date>
  <primary_completion_date type="Actual">January 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in SUVmax</measure>
    <time_frame>2 months</time_frame>
    <description>To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tumor volume</measure>
    <time_frame>2 months</time_frame>
    <description>To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Rectal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Adjuvant chemotherapy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chemoradiation</intervention_name>
    <arm_group_label>Adjuvant chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        20 patients with newly diagnosed rectal adenocarcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of histopathologically confirmed rectal adenocarcinoma.&#xD;
&#xD;
          -  Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should&#xD;
             clearly state both the T and N stage.&#xD;
&#xD;
          -  Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.&#xD;
&#xD;
          -  Age ≥18.&#xD;
&#xD;
          -  Ability to understand a written informed consent document and the willingness to sign&#xD;
             it.&#xD;
&#xD;
          -  Tumor must be determined to be surgically resectable. Surgical resection is planned to&#xD;
             take place at Univeristy of California, San Francisco (UCSF).&#xD;
&#xD;
          -  Neoadjuvant chemoradiation prior to resection is planned..&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ERUS tumor state of T1.&#xD;
&#xD;
          -  Radiographic evidence of metastatic disease&#xD;
&#xD;
          -  Weight in excess of limitations of the scanner or girth that prohibits entry into the&#xD;
             bore of the PET/CT scanner due to size.&#xD;
&#xD;
          -  Any medical condition which impairs the ability to lie flat and without movement for&#xD;
             15 minutes (e.g. cough, severe arthritis, etc.)&#xD;
&#xD;
          -  Prior receipt of any therapy, including local excision, radiation or chemotherapy, for&#xD;
             the diagnosed rectal adenocarcinoma.&#xD;
&#xD;
          -  Prior history of pelvic radiation.&#xD;
&#xD;
          -  Uncontrolled hyperglycemia (defined as inability to achieve a glucose of &lt;250 mg/dL at&#xD;
             time of fluorodeoxyglucose (FDG) injection).&#xD;
&#xD;
          -  Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) &lt; 30&#xD;
             mLs/min), which is a contraindication to gadolinium containing contrast.&#xD;
&#xD;
          -  Known allergy to gadolinium containing contrast agents.&#xD;
&#xD;
          -  Contraindication to use of fluoropyrimidines as a radiosensitizing agent.&#xD;
&#xD;
          -  Pregnancy or nursing. Women of child bearing potential must have a negative serum or&#xD;
             urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within&#xD;
             72 hours prior to randomization. This is because of the potential teratogenic effects&#xD;
             of the involved imaging modalities, radiation, and chemotherapy.&#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>Thomas Hope, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Imaging Center at China Basin</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>PET</keyword>
  <keyword>rectal cancer</keyword>
  <keyword>adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal 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/NCT02233595
org study id: 144513
secondary id: NCI-2015-00980
nct id: NCT02233595
lead sponsor: 
has dmc: No
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre-
      and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response
      on surgical resection.
observational model: Cohort
time perspective: Prospective
measure: change in SUVmax
time frame: 2 months
description: To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
measure: tumor volume
time frame: 2 months
description: To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
arm group label: Adjuvant chemotherapy
intervention type: Radiation
intervention name: Chemoradiation
arm group label: Adjuvant chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Hope, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rectal Neoplasms