Benchmarking Intra-tumor Heterogeneity In Ovarian Cancer: Linking In-vivo Imaging Phenotypes With Histology And Genomics

June 17, 2020 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography [PET] scans. No direct clinical benefits will come from the results of this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering West Harrison
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥18 years of age on the day of signing the informed consent.
  • Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer.
  • Scheduled to undergo primary debulking surgery.

Exclusion Criteria:

  • Pregnant patients
  • Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of ovarian cancer cannot give valid informed consent
  • Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
  • Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/
  • Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
  • Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
  • Stage not greater than IB
  • No more than superficial myometrial invasion
  • No vascular or lymphatic invasion
  • No poorly differentiated subtypes, including serous, clear cell, or other FIGO Grade 3 lesions.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. Patients may have received prior adjuvant chemotherapy for breast cancer.
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excluded.
  • Unresolved bowel obstruction.
  • History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study.
  • Absence of target lesions (> 2.0 cm) on staging CT
  • Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places [i.e. falciform ligament or porta hepatis], suprarenal retroperitoneal lymphadenopathy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI with DW-MRI & DCE-MRI & FDG PET/CT
Study participants will have 1 scan within the 7 days immediately preceding surgery (PET/CT as standard of care and MRI as a research exam). MRI and PET/CT scanning procedures will be identical to those used in routine clinical examinations of the abdomen and pelvis.
Procedure: MRI
Procedure: PET/CT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic markers of spatial heterogeneity
Time Frame: 1 year
by evaluating spatially explicit phenotypic clusters based on a combination of perfusion, diffusion and metabolic tumor profiles (maps) in both ovarian tumors and metastatic peritoneal/omental implants of patients with HGSOC undergoing primary debulking surgery (PDS).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological and immunohistochemical features
Time Frame: 1 year
The analyses involving the bioinformatic algorithms will be handled by the Bioinformatics Core. Previously validated bioinformatic algorithms (5, 13, 38) will be used to determine the clonal compositions of the imaging-based phenotypically distinct clusters of HGSOCs, and phylogenetic trees based on allelic frequencies of mutations and copy number aberrations of the primary ovarian tumor and matched metastatic implant will be constructed for each case
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Hebert Vargas Alvarez, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe