<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/NCT04454450</url>
  </required_header>
  <id_info>
    <org_study_id>20-212</org_study_id>
    <nct_id>NCT04454450</nct_id>
  </id_info>
  <brief_title>Using Advanced Imaging Studies to Develop a Profile of High-grade Serous Ovarian Cancer</brief_title>
  <official_title>Integration of Radiomic Analysis Into the Multi-Modal Profiling of High-Grade Serous Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are doing this study to find out whether the researchers can combine&#xD;
      information provided by PET/MRI scans with information from tests on blood and tissue samples&#xD;
      to develop a very detailed description (profile) of high-grade serous ovarian carcinoma&#xD;
      (HGSOC), which could improve our ability to treat this disease.&#xD;
&#xD;
      The study researchers will use computers to analyze the combined results of the imaging tests&#xD;
      and the genetic and immune system tests on the tumor samples. The study researchers think&#xD;
      that this information will help them more accurately predict the way tumors respond to&#xD;
      treatment, which may improve their ability to individualize treatments for this disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between radiologist tumor segmentation</measure>
    <time_frame>1 year</time_frame>
    <description>Radiologist-defined tumor volumes will be used to train and validate a machine learning algorithm for generating segmentations. The data will be split into 70%-30% of training and test sets, respectively. The comparisons will be performed on a slice-by-slice and lesion-bylesion basis, which should ensure sufficient numbers of examples for testing.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>High Grade Ovarian Serous</condition>
  <arm_group>
    <arm_group_label>Imaged prior to primary debulking surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imaged pre/postneoadjuvant chemotherapy (NACT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/MRI</intervention_name>
    <description>Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection.For research PET/MRI - standard volumes of gadolinium contrast and fluorodeoxyglucose (FDG) will be administered.</description>
    <arm_group_label>Imaged pre/postneoadjuvant chemotherapy (NACT)</arm_group_label>
    <arm_group_label>Imaged prior to primary debulking surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Contrast enhanced CT</intervention_name>
    <description>Standard of care contrast enhanced CT</description>
    <arm_group_label>Imaged pre/postneoadjuvant chemotherapy (NACT)</arm_group_label>
    <arm_group_label>Imaged prior to primary debulking surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age or older&#xD;
&#xD;
          -  Histologically confirmed or clinically suspected FIGO stage IIIC-IV HGSOC&#xD;
&#xD;
          -  Signed consent to MSK Institutional tissue banking protocol IRB# 06-107 and signed or&#xD;
             planned to sign IRB# 12-245, and planned to undergo multi-region tissue collection&#xD;
             [under the above IRB protocols] and plan to undergo subsequent tissue analysis under&#xD;
             biospecimen IRB# 15-200.&#xD;
&#xD;
          -  Staging standard-of-care contrast-enhanced CT of abdomen and pelvis (+/-chest)&#xD;
             available in picture archiving and communication system (PACS) that was obtained at&#xD;
             our institution as a part of standard-of-care work-up or submitted for from the&#xD;
             outside&#xD;
&#xD;
          -  Plasma glucose ≤200 mg/dL&#xD;
&#xD;
          -  Negative pregnancy test, if a patient is of child-bearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to gadolinium-based contrast medium requiring premedication or known&#xD;
             adverse reactions to gadolinium-based contrast medium.&#xD;
&#xD;
          -  Known history of impaired renal function, with documented eGFR &lt;30 within 30 days&#xD;
             prior to PET/MRI.&#xD;
&#xD;
          -  Patients who cannot give valid informed consent because of general medical or physical&#xD;
             condition, or physiologic status unrelated to presence of ovarian cancer&#xD;
&#xD;
          -  Patients who are unwilling or unable to undergo PET/MRI including patients with&#xD;
             absolute or relative contraindications to MRI including breast tissue expanders,&#xD;
             cardiac pacemakers and defibrillators, non MRI-compatible aneurysm clips,&#xD;
             neurostimulators, programmable CSF shunts, vascular stents, claustrophobia, or&#xD;
             inability to lie flat for the duration of the examination.&#xD;
&#xD;
          -  Patients with metallic hardware, implant, or device in the abdomen or pelvis that&#xD;
             might distort the local magnetic field and compromise image quality.&#xD;
&#xD;
          -  Radiotherapy to the abdomen or pelvis within 12 months of the screening visit.&#xD;
&#xD;
          -  Subjects with a current diagnosis of ovarian cancer other than HGSOC&#xD;
&#xD;
          -  Patients with known synchronous primary endometrial cancer or past history of&#xD;
             endometrial cancer.&#xD;
&#xD;
          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor.&#xD;
             Patients may have received prior adjuvant chemotherapy for breast cancer.&#xD;
&#xD;
          -  With the exception of non-melanoma skin cancer and other specific malignancies as&#xD;
             noted above, subjects with excluded known concurrent malignancy.&#xD;
&#xD;
          -  Unresolved bowel obstruction.&#xD;
&#xD;
          -  History or current evidence of any condition, therapy, or lab abnormality that might&#xD;
             confound the results of the study or interfere with patient's participation for the&#xD;
             full duration of the study.&#xD;
&#xD;
          -  Absence of any target lesions ( ≥1-2 cm) in the pelvis (right adnexa, left adnexa,&#xD;
             infra-colic omentum, pelvic peritoneum) visible on staging standard-of-care CE-CT and&#xD;
             accessible for tissue sampling at laparoscopy and/or primary/ interval debulking&#xD;
             surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Ovarian Cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viktoriya Paroder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FIGO stage IIIC-IV</keyword>
  <keyword>PET radiotracer</keyword>
  <keyword>20-212</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </patient_data>
  <!-- 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/NCT04454450
org study id: 20-212
nct id: NCT04454450
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The researchers are doing this study to find out whether the researchers can combine
      information provided by PET/MRI scans with information from tests on blood and tissue samples
      to develop a very detailed description (profile) of high-grade serous ovarian carcinoma
      (HGSOC), which could improve our ability to treat this disease.

      The study researchers will use computers to analyze the combined results of the imaging tests
      and the genetic and immune system tests on the tumor samples. The study researchers think
      that this information will help them more accurately predict the way tumors respond to
      treatment, which may improve their ability to individualize treatments for this disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison between radiologist tumor segmentation
time frame: 1 year
description: Radiologist-defined tumor volumes will be used to train and validate a machine learning algorithm for generating segmentations. The data will be split into 70%-30% of training and test sets, respectively. The comparisons will be performed on a slice-by-slice and lesion-bylesion basis, which should ensure sufficient numbers of examples for testing.
arm group label: Imaged prior to primary debulking surgery
arm group type: Experimental
description: Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).
arm group label: Imaged pre/postneoadjuvant chemotherapy (NACT)
arm group type: Experimental
description: In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).
intervention type: Diagnostic Test
intervention name: PET/MRI
description: Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection.For research PET/MRI - standard volumes of gadolinium contrast and fluorodeoxyglucose (FDG) will be administered.
arm group label: Imaged pre/postneoadjuvant chemotherapy (NACT)
arm group label: Imaged prior to primary debulking surgery
intervention type: Diagnostic Test
intervention name: Contrast enhanced CT
description: Standard of care contrast enhanced CT
arm group label: Imaged pre/postneoadjuvant chemotherapy (NACT)
arm group label: Imaged prior to primary debulking surgery
criteria: 
gender: Female
gender based: Yes
gender description: Ovarian Cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Viktoriya Paroder, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.