Radiofrequency Ablation (RFA) in Breast Tumors

Not Applicable

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT04389216
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.

Detailed Description

A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar.

Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure.

Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Primary Completion: 2025-09-09
• Study Completion: 2025-09-09
• Last Update Posted: 2025-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Infiltrating ductal carcinoma according the biopsy of the breast,
• Tumor visible by ultrasound, smaller than 2 cm,
• Located > 1 cm from the chest wall and the skin.

Exclusion Criteria

• Personal antecedents of breast cancer
• Multifocality or intraductal carcinoma
• Lobular infiltrating carcinoma
• Neoadjuvant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MRI post-RFA	"1 month"	Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).
BAG post-RFA	"1 month"	Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings (tumor viability scale: 0, \<25%, 25-50%, 50-75%, \> 75%).

Secondary Outcome Measures

Name	Time	Method
Quality	"1 month"	Breast-Q
Adverse Effects	"1 month"	Adverse effects related to radiofrequency

Trial Locations

Locations (2)

Hospital del Mar; 🇪🇸 Barcelona, Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain