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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946140
• Other study ID #: 08-132
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: October 23, 2013
• Start date: July 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center