Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer (BSMART)
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring breast cancer, magnetic resonance imaging
Eligibility Criteria
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
Sites / Locations
- Texas Tech University Health Sciences Center School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MRI
Non-MRI
Arm Description
Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)
Outcomes
Primary Outcome Measures
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Secondary Outcome Measures
Full Information
NCT ID
NCT00948285
First Posted
July 27, 2009
Last Updated
November 11, 2019
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT00948285
Brief Title
Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer
Acronym
BSMART
Official Title
Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult accrual
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, magnetic resonance imaging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Arm Description
Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
Arm Title
Non-MRI
Arm Type
No Intervention
Arm Description
Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
magnetic resonance imaging (MRI)
Primary Outcome Measure Information:
Title
A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakhshanda L Rahman, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center School of Medicine
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer
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