Breast Cancer Clinical Trial
— BSMARTOfficial title:
Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
NCT number | NCT00948285 |
Other study ID # | A09-3519 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2009 |
Est. completion date | December 2018 |
Verified date | November 2019 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 194 |
Est. completion date | December 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer. | 3 years |
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