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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00579800

Purpose

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.

Condition	Intervention
Breast Cancer	Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	76
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
women undergoing routine breast MRI: 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.	Procedure: 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579800

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Elizabeth Morris, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Elizabeth Morris, MD )
Study ID Numbers:	07-091
Study First Received:	December 20, 2007
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00579800 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Vibrant-DE
IDEAL
MRI
Breast

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009