Radiofrequency Ablation for Breast Cancer

(ABLATE Trial)

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Under 50, Male, Bilateral malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether radiofrequency ablation (RFA), a heat-based procedure, can reduce the need for additional surgery after breast tumor removal. It targets women who have undergone a lumpectomy, applying RFA to ensure no cancer cells remain. This trial may suit women aged 50 or older with a single, small breast tumor (3 cm or less) that does not affect the skin. Participants should have specific types of breast cancer, such as ductal carcinoma, and the cancer must be hormone receptor positive. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that radiofrequency ablation is safe for breast cancer treatment?

Research has shown that radiofrequency ablation (RFA) safely treats small breast cancers. It works well for tumors smaller than 2 cm, though further studies are needed to confirm this.

RFA is generally safe, but some side effects have occurred. One study reported that 9 patients experienced local pain, 15 had skin burns, and 7 experienced nipple retraction. This study followed patients for about four years, offering a comprehensive view of long-term effects.

Overall, RFA seems to be a promising and safe option for small breast cancers, but each person's experience may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency Ablation (RFA) is unique because it uses heat generated by radio waves to target and destroy cancer cells in the breast. Unlike traditional treatments like surgery or radiation, RFA is minimally invasive and aims to preserve more healthy tissue. Researchers are excited about RFA because it could potentially reduce recovery times and offer a less invasive option for patients, making it a promising alternative to current methods.

What evidence suggests that radiofrequency ablation is effective for breast cancer?

Research has shown that radiofrequency ablation (RFA) effectively destroys breast cancer cells. Studies have found RFA to be safe and promising for treating small breast cancers, particularly those less than 2 cm in size. In one study, RFA successfully destroyed cancer cells in 90% of cases. Another study confirmed that RFA can lead to the death of breast cancer cells, making it an appealing option for early-stage breast cancer. Although more research is needed to confirm these findings, early results are encouraging for using RFA as a treatment. In this trial, participants will undergo surgery followed by RFA to further evaluate its effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Daniela Ochoa, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for women over 50 with breast cancer where the tumor is ≤ 3 cm, unicentric, unilateral, and not involving the skin. It's suitable if the cancer is ductal in situ or infiltrating ductal carcinoma that's hormone receptor positive. Women can't join if they're under 50, have clinically positive lymph nodes, invasive lobular carcinoma, bilateral malignancy or had recent chemotherapy.

Inclusion Criteria

I am a woman aged 50 or older.

My tumor is located in one area and on one side of my body.

Patient signs current written informed consent and HIPAA forms

Exclusion Criteria

My breast cancer is invasive lobular carcinoma.

I am younger than 50 years old.

My tumor is larger than 3 cm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo breast conservation procedure (lumpectomy) followed by radiofrequency ablation (RFA) to extend tumor-free margins

Immediate post-surgery

1 visit (in-person)

Post-surgery Monitoring

Participants are monitored for re-excision needs and initial recovery

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on local recurrence

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Ablation

Trial Overview The study tests radiofrequency ablation (RFA) right after lumpectomy surgery to see if it helps extend tumor-free margins and reduce the need for more surgeries. RFA uses heat from radio waves to kill any remaining cancer cells around where the lump was removed.

How Is the Trial Designed?

Group I: Surgery followed by RFA Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Angiodynamics, Inc.

Industry Sponsor

Trials

27

Recruited

3,100+

Published Research Related to This Trial

Ultrasound-guided radiofrequency ablation (RFA) effectively reduced the volume of benign thyroid nodules in 1000 patients, achieving over 50% volume reduction in 78.9% of predominantly solid and 78.2% of predominantly cystic lesions after the first treatment, indicating its efficacy across different nodule types.

The only significant factor associated with successful treatment was a smaller nodule volume (less than 4 mL), suggesting that RFA is particularly effective for smaller nodules and can be considered a primary treatment option for benign thyroid nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. Lee, GM., You, JY., Kim, HY., et al.[2020]

Ultrasound-guided radiofrequency ablation (RFA) is effective in treating benign thyroid nodules, with significant volume reduction observed over a follow-up period of up to 48 months in a study of 119 patients.

Factors such as lower pre-treatment neck circumference and macrocystic echostructure were identified as positive predictors for achieving a volume reduction rate of 75% or more at 12 months, indicating that selecting appropriate nodules can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictor Analysis in Radiofrequency Ablation of Benign Thyroid Nodules: A Single Center Experience. Bisceglia, A., Rossetto, R., Garberoglio, S., et al.[2022]

Radiofrequency ablation (RFA) is a safe and effective non-surgical treatment for benign thyroid nodules, with long-term results showing significant volume reduction of nodules.

While RFA has a low risk of major complications (up to 3.8%), careful management of both minor and major complications is essential, and long-term follow-up is necessary to monitor for potential regrowth of nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Radiofrequency Ablation: Complications and Clinical Follow Up. Lim, JY., Kuo, JH.[2022]

Ultrasound-guided radiofrequency ablation (RFA) significantly reduced the size of metastatic well-differentiated thyroid carcinoma tumors in 10 patients, with the mean diameter decreasing from 13.8 mm to 3.3 mm after treatment.

RFA was effective in controlling tumor growth in patients who could not undergo surgery, with 83% of tumors treated in a single session and a notable decrease in serum thyroglobulin levels in 7 out of 10 patients, indicating a positive response to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locoregional control of metastatic well-differentiated thyroid cancer by ultrasound-guided radiofrequency ablation. Baek, JH., Kim, YS., Sung, JY., et al.[2022]

In a study of 250 patients undergoing ultrasound-guided radiofrequency ablation (RFA) for benign thyroid nodules, the volume reduction ratio (VRR) improved significantly over 12 months, indicating the treatment's efficacy.

Certain ultrasound characteristics, such as nodules being isoechoic, hyper-vascular, and located in the left lobe, were associated with higher success rates of RFA, suggesting that these factors can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ultrasound parameters of benign thyroid nodules on radiofrequency ablation efficacy. Motaghed, Z., Chegeni, H., Mosadeghkhah, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8126716/

Efficacy and Safety of Radiofrequency Ablation for Breast ... The results show that RFA for breast cancer smaller than 2 cm is safe and effective. However, prospective studies are needed to validate this conclusion.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12553941/

Comparative Analysis of Clinical Efficacy of High-Intensity ... HIFU group results at 3 months: Enlarged 13%, Stable 2%, Reduced 46%, Effectively Ablated 39%. At 6 months: Enlarged 2%, Stable 0%, Reduced 16%, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798313007786

Radiofrequency ablation for early-stage breast cancer It was concluded that RFA successfully leads to breast cancer cell death.12. RFA in patients with early-stage breast carcinoma may indeed be an appealing ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e12570

Multicenter study to evaluate the efficacy and standardize ... A 90% complete ablation rate was confirmed histopathologically. Our phase II multicenter study of RFA without resection for early breast cancer ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT97433

Radiofrequency ablation (RFA) of breast cancer Conclusions: RFA is considered to be a safe and promising minimally invasive treatment of small breast cancer ≤ 2 cm in diameter. Further studies are necessary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4115759/

Radiofrequency ablation and breast cancer: a review The main safety issue with RFA treatment involves outcomes of breast cancer recurrence and survival rates. As of now, follow up has been largely limited. The ...

7. esmoopen.com esmoopen.com/article/S2059-7029(25)00585-X/fulltext

162P RadioFrequency Ablation (RFA) therapy for early ... The prognosis of patients treated with RFA was similar to that of patients who underwent surgery to preserve breast cancer at the same stage of the disease.

8. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(17)30241-0/fulltext

Radiofrequency Ablation of Breast Cancer: A Retrospective ... RFA-related adverse events included local pain in 9 patients, skin burns in 15, and nipple retraction in 7. Patients were followed for a median of 50 months.