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NCT04389216 Clinical Trial

Radiofrequency Ablation (RFA) in Breast Tumors

Breast Cancer Female Clinical Trial

— RFA  

Official title:
Radiofrequency Ablation in Breast Tumors in Early Stages

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04389216
Other study ID # ICPS002/20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date December 15, 2024

Study information
Verified date February 2023
Source Hospital Universitari de Bellvitge
Contact Amparo Garcia-Tejedor, MDPhD
Phone 660223417
Email agarciat@bellvitgehospital.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender Female
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Cool-tip electrode for Radiofrequency Ablation
Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Locations
Country Name City State
Spain Hospital del Mar Barcelona
Spain Hospital de Bellvitge Hospitalet de Llobregat Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary MRI post-RFA Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement. 1 month after procedure
Primary BAG post-RFA Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings. 1 month after procedure
Secondary Adverse Effects Adverse effects related to radiofrequency Through study completion, an average of 1 year
Secondary Quality Breast-Q 1 month after procedure
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