The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Overview
Brief Summary
This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females 18-99 of age with recommendation for stereotactic biopsy.
Exclusion Criteria
- •Non-female patients
- •Patients \< 18 years old
- •Women who are pregnant
Outcomes
Primary Outcomes
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Time Frame: baseline through 1 hour (post biopsy mammogram/procedure)
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
Time Frame: baseline through 1 hour (post biopsy mammogram/procedure)
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
Time Frame: baseline through 1 hour (post biopsy mammogram/procedure)
This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
Time Frame: baseline through 1 hour (post biopsy mammogram/procedure)
Secondary Outcomes
No secondary outcomes reported
Investigators
Stefanie A. Woodard
Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section
University of Alabama at Birmingham