Breast CancerABLATENCT01153035
Excision Followed by Radiofrequency Ablation for Breast Cancer
A study testing Radiofrequency Ablation in people with Breast Cancer, run by University of Arkansas at 6 sites in United States.
Trial summary
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2010to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a female, ≥ 50 years of age
- The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
- The tumor is unicentric and unilateral
- The tumor is not involving the skin
- Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
- If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
- Patient signs current written informed consent and HIPAA forms
Who cannot join
- Patient is under 50 years of age
- Patient is male
- Tumor > 3 cm in diameter
- Bilateral malignancy
- Clinically positive lymph nodes
- Tumor involving the skin
Show all 10Show fewer
- Pathology confirms invasive lobular carcinoma
- Breast implants
- Less than 2 years disease-free survival from previous breast cancer
- Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Comprehensive Breast Care of Denver
Denver, Colorado, 80218
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Columbia
New York, New York, 10032
Sharp Oncology (Comprehensive Breast Care of San Diego)
San Diego, California, 92123
University of Arizona
Tucson, Arizona, 85704
The University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.
- Conditions
- Breast Cancer
- Being tested
- Radiofrequency Ablation
- Keywords
- Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
Also called AngioDynamics, Inc.
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
| Study group | Role | What they receive |
|---|---|---|
| Surgery followed by RFA | Other | Not described Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the re-excision rate for close (<3mm) or positive margins
How many patients must go back for re-excision of margins
Measured: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
Decrease local recurrence
The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.
Measured: Monitor throughout 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniela Ochoa, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153035
- Sponsor's protocol ID
- 104603
- Acronym
- ABLATE
- Status last verified
- Nov 2025
- First submitted
- 24 Jun 2010
- Last updated
- 10 Nov 2025
- Results posted
- No
Publications
Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.
PubMed 24655863Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16.
PubMed 22422482Wilson M, Korourian S, Boneti C, Adkins L, Badgwell B, Lee J, Suzanne Klimberg V. Long-term results of excision followed by radiofrequency ablation as the sole means of local therapy for breast cancer. Ann Surg Oncol. 2012 Oct;19(10):3192-8. doi: 10.1245/s10434-012-2476-2. Epub 2012 Aug 22.
PubMed 22911363
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT01153035
- Acronym / sponsor ID
- ABLATE / 104603
- Conditions
- Breast Cancer
- Keywords
- Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Study start
- Jun 2010
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jun 2010 (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.
The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery followed by RFA | Other | Device: Radiofrequency Ablation |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is a female, ≥ 50 years of age
- The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
- The tumor is unicentric and unilateral
- The tumor is not involving the skin
- Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
Key exclusion criteria (10 listed)
- Patient is under 50 years of age
- Patient is male
- Tumor > 3 cm in diameter
- Bilateral malignancy
- Clinically positive lymph nodes
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 |
|---|---|---|
| Radiofrequency AblationAlso: AngioDynamics, Inc.Breast conservation surgery followed by Radiofrequency Ablation of the cavity | Device | Surgery followed by RFA |
Primary outcome
Estimate the re-excision rate for close (<3mm) or positive margins
Time frame: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
How many patients must go back for re-excision of margins
Decrease local recurrence
Time frame: Monitor throughout 5 year follow-up
The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Background: PubMed 24655863Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.
- Results publication: PubMed 22422482Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16.
- Results publication: PubMed 22911363Wilson M, Korourian S, Boneti C, Adkins L, Badgwell B, Lee J, Suzanne Klimberg V. Long-term results of excision followed by radiofrequency ablation as the sole means of local therapy for breast cancer. Ann Surg Oncol. 2012 Oct;19(10):3192-8. doi: 10.1245/s10434-012-2476-2. Epub 2012 Aug 22.
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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.
Daniela Ochoa, MD principal investigator
University of Arkansas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Breast Cancer, run by University of Arkansas at 6 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Estimate the re-excision rate for close (<3mm) or positive margins (time frame: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)). The study lists 2 primary outcomes in all. 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 NCT01153035, which also lists 3 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 10 Nov 2025.