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

18 Years
Open (Enrolling by invite only)
Breast Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Rakhshanda L Rahman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Texas Tech University Health Sciences Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • magnetic resonance imaging
  • Breast Neoplasms



Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106