Radiofrequency Ablation for Breast Cancer

(ABLATE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Daniela Ochoa, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

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.

Treatment Details

Interventions

• Radiofrequency Ablation (Other)

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+

Dr. Brent D. Williams

University of Arkansas

Chief Executive Officer since 2023

Ph.D. in Business Administration from the University of Arkansas

Dr. Racheal Adams

University of Arkansas

Chief Medical Officer since 2023

Doctor of Pharmacy from the University of Arkansas for Medical Sciences

Angiodynamics, Inc.

Industry Sponsor

Trials

27

Recruited

3,100+