Breast CancerNCT00529737
Effect on Clip Markers After Vacuum-Assisted Biopsy by Postprocedure Mammogram
A study testing Breast Biopsy and Post Procedure Mammogram in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Biopsy and Post Procedure Mammogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast Biopsy, Post Procedure Mammogram
- Keywords
- Breast Cancer, Marker Clip Migration, Vacuum-Assisted Biopsy, Postprocedure Mammogram, Breast Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast BiopsyProcedure or surgery
Stereotactic-guided breast biopsy via standard practice of care
Post Procedure MammogramProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Breast Biopsy; Procedure: Post Procedure Mammogram |
| Group 2 | Experimental | Post Procedure Mammogram Projection View B than View A Receives: Procedure: Breast Biopsy; Procedure: Post Procedure Mammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Traveled by Breast Clip
Measured: Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huong T. Le-Petross, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529737
- Sponsor's protocol ID
- 2006-0434
- Status last verified
- Jul 2012
- First submitted
- 13 Sep 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Clip Markers Migration After Vacuum-Assisted Biopsy by Postprocedure Mammogram
- ClinicalTrials.gov ID
- NCT00529737
- Acronym / sponsor ID
- 2006-0434
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Marker Clip Migration, Vacuum-Assisted Biopsy, Postprocedure Mammogram, Breast Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Breast Biopsy, Procedure: Post Procedure MammogramPost Procedure Mammogram Projection View A -- (view same projection as used in the biopsy procedure), then View B (view orthogonal projection to the first view). |
| Group 2 | Experimental | Procedure: Breast Biopsy, Procedure: Post Procedure MammogramPost Procedure Mammogram Projection View B than View A |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast BiopsyStereotactic-guided breast biopsy via standard practice of care | Procedure or surgery | Group 1, Group 2 |
| Post Procedure MammogramView 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). | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Distance Traveled by Breast Clip
Time frame: Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huong T. Le-Petross, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Biopsy and Post Procedure Mammogram in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Traveled by Breast Clip (time frame: Pre-biopsy and post-biopsy mammograms, and follow up 1 year post biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.