Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer (BSMART)

November 11, 2019 updated by: Texas Tech University Health Sciences Center

Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)

The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

We propose that the role of preoperative staging-MRI in breast cancer be studied by following the occurrence of negative margins at first surgery and the volume of resection in a randomized prospective study. The need for re-excision is an objective marker of satisfactory local surgery and is available as soon as the final pathology report is back. We propose that the closest margin and the rate of re-excision be used as the primary outcome measures to evaluate the contribution of MRI. In addition, since cosmetic preservation is one of the goals of breast conservation, we propose that cosmetic outcome be used as the secondary outcome measure. The visual analogue scale for cosmetic outcome varies between observers and with time; however, the volume of tissue that is excised is an objective surrogate of cosmetic outcome.15 Since the excised volume is dictated by the tumor volume, the only variable under the surgeon's control is the volume of benign tissue excised in order to obtain negative margins. Hence, in this study, we propose to use a volume index of excised margins as an outcome measure for cosmesis. The index value will be calculated for each subject by adding the two measurements of benign margin for each of the three dimensions measured and multiplying them to produce a volume index for each subject.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Newly diagnosed breast cancer patients
  • Breast cancer patients identified as conservation candidates by their surgeons

Exclusion Criteria:

  • Patients with a history of prior breast cancer treatment (recurrence)
  • Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study)
  • Patients with documented sensitivity to gadolinium (contrast agent used during MRI)
  • Patients who weigh more than 350 pounds (weight limit on MRI machine)
  • Patients who receive neoadjuvant chemotherapy
  • Patients with renal insufficiency (serum Cr > 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI
Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
Procedure: MRI
magnetic resonance imaging (MRI)
No Intervention: Non-MRI
Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Rakhshanda L Rahman, MD, Texas Tech University Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A09-3519

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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