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Completed

NCT Number: NCT04389216

Radiofrequency Ablation (RFA) in Breast Tumors

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

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Key information

Conditions

Breast Cancer Female

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar, Barcelona, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cool-tip electrode for Radiofrequency Ablation

Device

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

Primary outcomes

  1. MRI post-RFA

    Time frame: "1 month"

    Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).

  2. BAG post-RFA

    Time frame: "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 outcomes

  1. Adverse Effects

    Time frame: "1 month"

    Adverse effects related to radiofrequency

  2. Quality

    Time frame: "1 month"

    Breast-Q

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

Radiofrequency Ablation in Breast Tumors in Early Stages

Acronym: RFA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 15, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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