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

Completed

• Conditions: Ovarian Cancer
• Interventions: Procedure: DCE-MRI scans

• Registration Number: NCT00946140
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ovarian cancer currently undergoing treatment	DCE-MRI scans	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States