Motion Correction in Dynamic Contrast Enhanced Magnetic Resonance Imaging (MRI) in Ovarian Cancer: A Pilot Study

October 23, 2013 updated by: Memorial Sloan Kettering Cancer Center

Motion Correction in Dynamic Contrast Enhanced MRI in Ovarian Cancer: A Pilot Study

The purpose of this study is to develop new image analysis method using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part of the standard care for ovarian cancer. In this method, a contrast agent is used to make ovarian cancer visible during imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

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
      • 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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The patients will be recruited from the existing patient population at Gynecologic Medical Oncology Service at MSKCC. The patients meeting the eligibility criteria will be referred to DCE-MRI study by a physician in the GMO service at MSKCC.

Description

Inclusion Criteria:

  • Patients with measurable disease with evidence of at least one uni-dimensionally measurable tumor (> 1 cm) by CT or MRI scan according to RECIST (Response Evaluation Criteria in Solid Tumors) that the tumor has not been initially treated with surgery or radiation therapy.
  • Patients who will start treatment with bevacizumab combined with or without cytotoxic chemotherapy within 14 days from signing consent. Patients treated on an approved IRB therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible.
  • Patients with histologically confirmed ovarian epithelial cancer including primary peritoneal and fallopian tube adenocarcinoma.
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception.
  • Patients who are older than 21 years of age.
  • Patients who are able to understand and sign informed consent.

Exclusion Criteria:

  • Patients treated on an approved IRB therapeutic protocol with a blinded arm of bevacizumab or placebo are not eligible (IRB 07-078 and IRB 05-138).
  • Patients with cardiac pacemakers.
  • Patients with certain prosthetic devices and implants who are not compatible with the high magnetic field present in the DCE-MRI scanners.
  • Patients who have experienced a prior adverse reaction to the gadolinium complex contrast agent used in DCE-MRI imaging and who don't meet criteria for creatinine and nephrogenic systemic sclerosis risk per guidelines of department of radiology.
  • Patients prone to claustrophobia.
  • Patients on dialysis.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with ovarian cancer currently undergoing treatment
All of the patients will be treated per their treatment protocols by their physicians and they will be referred to this study for the DCE-MRI scans at baseline, within 24-48 hours of the start of the therapy, and within 6-8 weeks of the start of the therapy.
Procedure: DCE-MRI scans
Initially you will be given safety information about MRI scans and a questionnaire to determine your compatibility with the MRI scanner. For each patient, DCE-MRI data sets will be acquired three times - at baseline just prior to the start of the drug therapy, within 24-48 hours of the start of the therapy, and within 6-8 weeks of the start of the therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of automated motion correction algorithms and new functional methods that permit use of DCE-MRI in primary or metastatic tumors of the ovaries.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Testing of new methods using the DCE-MRI data sets for comparing changes in tumor perfusion with and without motion correction post anti-angiogenic therapy in ovarian cancer.
Time Frame: 2 years
2 years

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: David Gultekin, Ph.D., 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

July 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimate)

July 24, 2009

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-132

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.

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