Radiofrequency Ablation (RFA) in Breast Tumors (RFA)

February 28, 2023 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Radiofrequency Ablation in Breast Tumors in Early Stages

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency
Radiofrequency Ablation of breast cancer tumour by Cool-tip electrode.
Device: Cool-tip electrode for Radiofrequency Ablation
Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: Through study completion, an average of 1 year
Adverse effects related to radiofrequency
Through study completion, an average of 1 year
Quality
Time Frame: 1 month after procedure
Breast-Q
1 month after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Amparo Garcia-Tejedor, MDPhD, Hospital Universitari Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

December 15, 2024

Study Completion (Anticipated)

December 15, 2024

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICPS002/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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