Know Cancer

or
forgot password

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


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Distance Traveled by Breast Clip

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Huong T. Le-Petross, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0434

NCT ID:

NCT00529737

Start Date:

December 2006

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Marker Clip Migration
  • Vacuum-Assisted Biopsy
  • Postprocedure Mammogram
  • Breast Biopsy
  • Breast Neoplasms

Name

Location

U.T. M.D. Anderson Cancer CenterHouston, Texas  77030