Breast CancerPhase 1/2NCT00574301
Percutaneous Removal and Margin Ablation for Breast Cancer
A Phase 1/2 study testing Percutaneous Removal and Margin Ablation in people with Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Percutaneous Removal and Margin Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Oct 2011
- Phase
- Phase 1/2
- 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18 to 90 years of age
- Non-pregnant, not breastfeeding
- Pre-study documentation of:
- Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
- Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
- Location of abnormality > 1 cm from the skin
Show all 14Show fewer
- Ductal Carcinoma, Invasive (Grade I-III) or In-Situ
- No palpable axillary or supraclavicular lymph nodes
- Good general health
- Zubrod Performance Status of 0, 1, or 2
- If prior non-breast malignancy, must have 5 year disease-free survival
- No prior chemotherapy
- Hormonal therapy must be stopped
- Therapy with tamoxifen must have been of 14 days or less duration
Who cannot join
- Subjects less than 18 years of age or greater than 90 years of age
- Pregnant or breastfeeding
- Male
- Prior Breast Biopsy affected breast
- Breast implants
- Multicentric disease, bilateral disease
Show all 10Show fewer
- Residual disease after IVEB of > 1cm on MRI
- Lesions > 1.5 cm in diameter
- Lesions < 1 cm from skin surface
- Previous radiation therapy to the breast
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205
About this study
We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).
Read the detailed description
Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.
- Conditions
- Breast Cancer
- Being tested
- Percutaneous Removal and Margin Ablation
- Keywords
- Image Guided Vacuum Assisted Biopsy, Radiofrequency Ablation, Breast Conservation Therapy, Mastectomy, MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Removal and Margin AblationProcedure or surgery
Also called Mammotome Breast Biopsy System (IVEB), Ethicon Endo-Surgery, Radiofrequency Ablation (RFA), RITA Medical Systems, Lumpectomy, Mastectomy
Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Percutaneous Removal and Margin Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
Measured: Post-surgical pathology review
Secondary outcomes (1)
The proportion of patients with viable tumor cells beyond the margin
Measured: Post-surgical pathology review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startMar 2002
- Primary completionOct 2007
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Ethicon Endo-Surgery, RITA Medical Systems
- Responsible party
- Sponsor
- Investigators
- V. Suzanne Klimberg, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574301
- Sponsor's protocol ID
- UAMS 07050
- Other IDs
- NIH Grant 5 R21 CA097715-01
- Status last verified
- Jul 2013
- First submitted
- 14 Dec 2007
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554. doi: 10.1016/s0002-9610(02)01099-1.
PubMed 12488164Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.
PubMed 21904959
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Removal and Margin Ablation for Breast Cancer
- ClinicalTrials.gov ID
- NCT00574301
- Acronym / sponsor ID
- UAMS 07050
- Conditions
- Breast Cancer
- Keywords
- Image Guided Vacuum Assisted Biopsy, Radiofrequency Ablation, Breast Conservation Therapy, Mastectomy, MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Ethicon Endo-Surgery, RITA Medical Systems
- Study start
- Mar 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Dec 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.
We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).
Detailed description
Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Percutaneous Removal and Margin Ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female, 18 to 90 years of age
- Non-pregnant, not breastfeeding
- Pre-study documentation of:
- Size ≤1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration
- Uni-centricity, unilateral cancer by radiology (mammogram and MRI)
Key exclusion criteria (10 listed)
- Subjects less than 18 years of age or greater than 90 years of age
- Pregnant or breastfeeding
- Male
- Prior Breast Biopsy affected breast
- Breast implants
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 |
|---|---|---|
| Percutaneous Removal and Margin AblationAlso: Mammotome Breast Biopsy System (IVEB), Ethicon Endo-Surgery, Radiofrequency Ablation (RFA), RITA Medical Systems, Lumpectomy, MastectomyPatients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing. | Procedure or surgery | 1 |
Primary outcome
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation
Time frame: Post-surgical pathology review
1 secondary outcome
The proportion of patients with viable tumor cells beyond the margin
Time frame: Post-surgical pathology review
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 25 Jul 2013.
- Background: PubMed 12488164Johnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554. doi: 10.1016/s0002-9610(02)01099-1.
- Results publication: PubMed 21904959Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.
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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.
V. Suzanne Klimberg, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Percutaneous Removal and Margin Ablation in people with Breast Cancer, run by University of Arkansas 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 14 inclusion and 10 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 25 Jul 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation (time frame: Post-surgical pathology review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00574301, which also lists 2 linked publications.
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 25 Jul 2013.