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Radiofrequency Ablation in Breast Cancer

NCT02281812 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-06-04

No results posted yet for this study

Summary

Background/Main objective: Radiofrequency ablation (RFA) is a minimally invasive procedure widespread accepted in the treatment of different tumors, especially in the liver but its benefit is not yet well-known in breast cancer.

Our main objective is to evaluate the usefulness of RFA in \< 2cm malignant breast tumors to reduce the proportion of positive margins.

Methodology: The investigator propose a single-center, single-blind, phase I and II randomized controlled trial. Phase I:Security of the cool-tip cluster electrode assessing the potential adverse effects in three stages: initial,intermediate and final. Phase II: Randomized clinical trial, 2 parallel groups with 37 patients in each one.

Experimental group: percutaneous RFA previous to conventional lumpectomy. Control group: conventional surgery with lumpectomy. The number of positive margins in both groups, and the need of extending margin resection will be assessed intraoperatively. Inclusion criteria: women \>40 years, infiltrating ductal breast carcinoma by biopsy. The tumor must be unique, visible by ultrasound, smaller than 2cm and located \> 1 cm from the chest wall and the skin. Patients will be followed up for a period of two years to assess cosmetic result, short -term and long -term complications and recurrences.

Expected results: The "cool-tip" (cluster) ablation method reduces by at least 30% the risk of intraoperative extensions for positive margins during lumpectomy compared to conventional surgery in breast tumors with a diameter \< 2 cm.

Therefore this procedure may reduce the risk of second surgeries and the removed volume of tissue.Consequently the final cosmetic result should be improved.

Conditions

Interventions

PROCEDURE

Radiofrequency ablation

After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H\&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Amparo Garcia-Tejedor, MDPhD · Hospital Universitario Bellvitge-Idibell_Universidad de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281812 on ClinicalTrials.gov