Effect on Clip Markers After Vacuum-Assisted Biopsy by Postprocedure Mammogram

NCT00529737 | Completed DMC

• 1 other identifier: 2006-0434
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: \- To perform a prospective study to determine if there is a different in the marker clip migration if the first post-biopsy mammogram was performed in the same projection as the core biopsy versus in the orthogonal projection.

Conditions

Breast Cancer

Keywords

Breast Cancer; Marker Clip Migration; Vacuum-Assisted Biopsy; Postprocedure Mammogram; Breast Biopsy

Outcome Measures

Primary Outcomes (1)

• Distance Traveled by Breast Clip

  Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy

Study Arms (2)

Group 1

EXPERIMENTAL

Post Procedure Mammogram Projection View A -- (view same projection as used in the biopsy procedure), then View B (view orthogonal projection to the first view).

Procedure: Breast Biopsy; Procedure: Post Procedure Mammogram

Group 2

EXPERIMENTAL

Post Procedure Mammogram Projection View B than View A

Procedure: Breast Biopsy; Procedure: Post Procedure Mammogram

Interventions

Breast Biopsy PROCEDURE

Stereotactic-guided breast biopsy via standard practice of care

Group 1; Group 2

Post Procedure Mammogram PROCEDURE

View of post-procedure mammogram same projection as used in the biopsy procedure (View A), and mammographic view orthogonal projection to the first view (View B).

Group 1; Group 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who present to M. D. Anderson for a stereotactic guided 9 gauge vacuum-assisted breast biopsy and undergo stereotactic biopsy with biopsy clip deployment would be considered for the study.

You may not qualify if:

• If patient refuses biopsy or the biopsy is cancelled they will not be eligible.
• No biopsy clip is seen on the immediate postprocedure mammogram and no additional clip will be deployed.
• Pregnant women are excluded from the study.
• Patients who have had a previous biopsy or surgery in the same (ipsilateral) breast are excluded from the study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Huong T. Le-Petross, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: December 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)