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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Rakhshanda L Rahman, MD
Texas Tech University Health Sciences Center
United States: Institutional Review Board
|Texas Tech University Health Sciences Center School of Medicine||Amarillo, Texas 79106|