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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579800
• Other study ID #: 07-091
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: May 9, 2016
• Start date: July 2007
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00514319

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

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	To evaluate the feasibility of three new pulse sequences for breast MRI using newly developed software; FIESTA, Vibrant DE and IDEAL		conclusion of the study	No
Secondary	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.		conclusion of the study	No

External Links

•   Memorial Sloan Kettering Web Site