Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment new software sequences, fiesta and vibrant-de and ideal
Sponsor Memorial Sloan Kettering Cancer Center
Start date July 2007
End date December 2016
Trial size 76 participants
Trial identifier NCT00579800, 07-091, NCT00514319

Summary

The purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (MRI). The information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.
new software sequences, fiesta and vibrant-de and ideal
Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.

Primary Outcomes

Measure
To evaluate the feasibility of three new pulse sequences for breast MRI using newly developed software; FIESTA, Vibrant DE and IDEAL
time frame: conclusion of the study

Secondary Outcomes

Measure
To quantitatively and qualitatively assess performance of the three breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences.
time frame: conclusion of the study

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Female patients over the age of 21 undergoing a diagnostic Breast MRI. Exclusion Criteria: - Patients who would be normally excluded from undergoing an MRI examination - Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. - Patients under the age of 21. - Female patients who are pregnant.

Additional Information

Official title Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation
Principal investigator Elizabeth Morris, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.