NCT01409226

3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women

A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve in diagnosing breast cancer in women with high-risk of breast cancer.

Detailed description

Life time risk of developing breast cancer is greatly elevated in women with familial breast cancer, especially in BRCA carriers. Prevention and early detection strategies in these high risk women include risk reducing surgery, chemoprevention and close surveillance with semiannual clinical breast exams and yearly mammograms starting at age 25-35. Unfortunately, screening mammography detects only half the breast cancers in mutation carriers, presumably due to higher breast density in the younger women and perhaps due to inherent characteristics of their tumors such as rapid growth. In light of these limitations in this high risk group, some have suggested incorporation of semiannual mammograms and/or other imaging modalities such as ultrasound (US) and MRI. In this study, high risk women who have a suspicious mammographic lesion - categorized as Breast Imaging Reporting and data System (BI-RADS) 4 will be recruited to undergo a breast MRI before to a biopsy of the suspicious abnormality. All women will undergo a biopsy as a part of her standard of care. The results of the MRI will not influence our decision on whether a biopsy should be performed. The MRI results will be compared with the biopsy results with pathology as the gold standard.

Conditions

• Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation

Interventions

Type	Name	Description
DEVICE	3.0-T MRI	Participants undergo MRI prior to biopsy.
PROCEDURE	biopsy	Participants undergo breast biopsy after 3.0-T MRI.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-08-04
• Last updated: 2012-04-05

Locations

1 site across 1 country: United States