The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies

Overview

This will be a single-center prospective randomized control trial that IRB-approved study. The study plans to enroll 250 female patients presenting to 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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2022

Interventions

  • Device: 5mm retraction of clip deployment apparatus.
    • Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
  • Device: No retraction of clip deployment apparatus.
    • This is one method of standard of care and the clip will be deployed at the biopsy site.

Arms, Groups and Cohorts

  • Experimental: 5mm retraction of clip deployment apparatus
    • The participants in this group will have clip placement 5mm in front of the biopy site site.
  • Active Comparator: no retraction of clip deployment apparatus
    • These participants will the clip delivered at the biopsy site.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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)
  • Average distance of clip migration for the arm that did not receive clip retraction.
    • Time Frame: baseline through 1 hour (post biopsy mammogram/procedure)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stefanie A. Woodard, Assistant Program Director, Diagnostic Radiology Residency Program Assistant Professor, Breast Imaging Section – University of Alabama at Birmingham
  • Overall Official(s)
    • Stefanie Woodard, MD, Principal Investigator, University of Alabama at Birmingham
  • Overall Contact(s)
    • Stephanie Ford, BS, 205-934-4080, smford@uabmc.edu

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