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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type OTHER

Breast MRI

No MRI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MRI

Breast MRI

Intervention Type OTHER

Eligibility Criteria

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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

* Not pregnant or breastfeeding
* No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
* No prior mantle radiation
* No locally advanced breast cancer
* No diffuse malignant appearing microcalcifications requiring mastectomy
* No known collagen vascular disease
* No previous ipsilateral radiation
* No participants who undergo surgery at an outside institution
* No prior history of breast carcinoma

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No