Radiofrequency Ablation (RFA) in Breast Tumors

Catalan Institute of Health

Status: Completed

Conditions: Breast Cancer Female

Treatments: Device: Cool-tip electrode for Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04389216

ICPS002/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Radiofrequency Ablation Tumor

Experimental group

Description:

Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.

Treatment:

Device: Cool-tip electrode for Radiofrequency Ablation