Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

Dana-Farber Cancer Institute

Status and phase

Terminated

Phase 3

Conditions

Breast Cancer

Treatments

Other: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT01568346

11-330

Details and patient eligibility

About

This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.

Full description

This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.

The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must undergo definitive local therapy with either breast conserving therapy or mastectomy
Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
Able to undergo breast MRI

Exclusion criteria