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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Biopsy
Post Procedure Mammogram
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Marker Clip Migration, Vacuum-Assisted Biopsy, Postprocedure Mammogram, Breast Biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • U.T. M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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).

Post Procedure Mammogram Projection View B than View A

Outcomes

Primary Outcome Measures

Distance Traveled by Breast Clip

Secondary Outcome Measures

Full Information

First Posted
September 13, 2007
Last Updated
July 26, 2012
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00529737
Brief Title
Effect on Clip Markers After Vacuum-Assisted Biopsy by Postprocedure Mammogram
Official Title
The Effect on Clip Markers Migration After Vacuum-Assisted Biopsy by Postprocedure Mammogram
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Marker Clip Migration, Vacuum-Assisted Biopsy, Postprocedure Mammogram, Breast Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Post Procedure Mammogram Projection View B than View A
Intervention Type
Procedure
Intervention Name(s)
Breast Biopsy
Intervention Description
Stereotactic-guided breast biopsy via standard practice of care
Intervention Type
Procedure
Intervention Name(s)
Post Procedure Mammogram
Intervention Description
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).
Primary Outcome Measure Information:
Title
Distance Traveled by Breast Clip
Time Frame
Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huong T. Le-Petross, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.T. M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

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

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