Radiofrequency Ablation (RFA) in Breast Tumors

Not Applicable

Recruiting

• Conditions: Breast Cancer Female
• Interventions: Device: Cool-tip electrode for Radiofrequency Ablation

• 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: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
Radiofrequency	Cool-tip electrode for Radiofrequency Ablation	Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.

Primary Outcome Measures

Name	Time	Method
MRI post-RFA	1 month after procedure	Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement.
BAG post-RFA	1 month after procedure	Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings.

Secondary Outcome Measures

Name	Time	Method
Quality	1 month after procedure	Breast-Q
Adverse Effects	Through study completion, an average of 1 year	Adverse effects related to radiofrequency

Trial Locations

Locations (2)

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

Hospital del Mar; 🇪🇸 Barcelona, Spain