Radiofrequency Ablation for Breast Cancer

(ABLATE Trial)

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

104 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Radiofrequency Ablation for Breast Cancer?

Research shows that radiofrequency ablation (RFA), which uses heat to destroy tissue, is effective in treating thyroid nodules and thyroid cancer, suggesting it may also be beneficial for breast cancer. A pilot study on breast cancer patients showed that RFA could safely destroy tumor tissue, indicating its potential as a treatment option. ^{1 2 3 4 5}

Is radiofrequency ablation generally safe for humans?

Radiofrequency ablation (RFA) has been shown to be a consistently safe treatment for thyroid nodules, with major complications occurring in up to 3.8% of cases. It is less invasive than surgery and has excellent long-term results, although some minor and major complications can occur. ^{1 2 4 6 7}

How does radiofrequency ablation treatment for breast cancer differ from other treatments?

Radiofrequency ablation (RFA) for early-stage breast cancer is unique because it is a less invasive treatment that uses heat to destroy cancer cells, potentially leading to better cosmetic outcomes compared to traditional surgery. ^{2 3 8 9 10}

What is the purpose of this trial?

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.

Research Team

Daniela Ochoa, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Predictor Analysis in Radiofrequency Ablation of Benign Thyroid Nodules: A Single Center Experience. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Locoregional control of metastatic well-differentiated thyroid cancer by ultrasound-guided radiofrequency ablation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of primary thyroid carcinoma: efficacy according to the types of thyroid carcinoma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Successful radiofrequency ablation strategies for benign thyroid nodules. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation in patients with primary breast carcinoma: a pilot study in 26 patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation of benign cold thyroid nodules: initial clinical experience. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Radiofrequency Ablation: Complications and Clinical Follow Up. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation for early-stage breast cancer: treatment outcomes and practical considerations. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effect of ultrasound parameters of benign thyroid nodules on radiofrequency ablation efficacy. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Meta-analysis of radiofrequency ablation for treating the local recurrence of thyroid cancers. [2018]