Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

October 21, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To quantitatively and qualitatively assess performance of the two breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00579800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

Official Title ^ICMJE

Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00579800

Responsible Party

Elizabeth Morris, MD, Memorial Sloan-Kettering Cancer Center

Study ID Numbers ^ICMJE

07-091

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Elizabeth Morris, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP