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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579800
First received: December 20, 2007
Last updated: January 31, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: women undergoing routine breast MRI
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579800     History of Changes
Obsolete Identifiers: NCT00514319
Other Study ID Numbers: 07-091
Study First Received: December 20, 2007
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Vibrant-DE
IDEAL
MRI
Breast
07-091

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014