Effect on Clip Markers After Vacuum-Assisted Biopsy by Postprocedure Mammogram
NCT ID: NCT00529737
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2006-12-31
2009-03-31
Brief Summary
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\- 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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).
Breast Biopsy
Stereotactic-guided breast biopsy via standard practice of care
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).
Group 2
Post Procedure Mammogram Projection View B than View A
Breast Biopsy
Stereotactic-guided breast biopsy via standard practice of care
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).
Interventions
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Breast Biopsy
Stereotactic-guided breast biopsy via standard practice of care
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Huong T. Le-Petross, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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U.T. M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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2006-0434
Identifier Type: -
Identifier Source: org_study_id