Radiofrequency Ablation (RFA) in Breast Tumors

Radiofrequency Ablation in Breast Tumors in Early Stages

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04389216

Acronym

RFA

Enrollment

Registered

2020-05-15

Start date

2020-05-01

Completion date

2025-09-09

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Keywords

radiofrequency, early stage

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.

Interventions

DEVICECool-tip electrode for Radiofrequency Ablation

Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Radiofrequency ablation

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse Effects	1 month	Adverse effects related to radiofrequency
Quality	1 month	Breast-Q

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026