Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 1/10/2019 |
| Start Date: | July 2009 |
| End Date: | December 2019 |
| Contact: | Rakhshanda L Rahman, MD |
| Email: | rakhshanda.rahman@ttuhsc.edu |
| Phone: | 806-354-5543 |
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.
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.
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.
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
We found this trial at
1
site
Amarillo, Texas 79106
Principal Investigator: Rakhshanda L Rahman, MD
Phone: 806-354-5543
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