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

July 26, 2012 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

You are scheduled to have a biopsy because a lesion was seen on your mammogram. Sometimes, the lesion is completely removed during the biopsy. Therefore, a clip is usually placed to mark the biopsy site. If some of the tissue in this area needs to be removed by a surgeon at a later date, the clip will mark the area for your surgeon to remove.

All participants in this study will already be scheduled for a stereotactic biopsy with clip placement followed by a mammogram, as a part of the standard of care. You will need to sign a separate consent document for these procedures.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 teaspoon) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test before they can take part in this study.

If you are eligible and you choose to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two study groups. There will be an equal chance of being assigned to either group.

If you are assigned to Group 1, your breast will be compressed the same way as the breast was compressed during the biopsy in the first mammogram picture. In the second picture, your breast will be compressed the opposite way (a 90-degree rotation) from the way the first picture was done.

If you are assigned to Group 2, your breast will be compressed in a 90-degree rotation from the way the breast was compressed during your biopsy in the first mammogram picture. In the second picture, your breast will be compressed the same way as during the biopsy.

A researcher will review the mammogram to measure and record the distance of the biopsy clip from the biopsied lesion.

If your biopsy is benign (non-cancerous), you will return to the clinic for a mammogram once a year, as is standard of care. Researchers would like to review the mammogram that is taken 1 year after the biopsy in order to check to see if the clip has moved or stayed in the same place.

This is an investigational study. The clip used in this study is FDA approved. Up to 60 patients will take part in the study. All will be enrolled at M.D. Anderson Cancer Center.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T. M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
Stereotactic-guided breast biopsy via standard practice of care
Procedure: Post Procedure Mammogram
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).
Experimental: Group 2
Post Procedure Mammogram Projection View B than View A
Procedure: Breast Biopsy
Stereotactic-guided breast biopsy via standard practice of care
Procedure: Post Procedure Mammogram
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distance Traveled by Breast Clip
Time Frame: Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy
Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Huong T. Le-Petross, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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