Radiofrequency Ablation in Breast Cancer

May 31, 2018 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

Impact of Radiofrequency Ablation on Surgical Margins in Early Stage of Malignant Breast Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Main objectives of the project:

  • To evaluate the usefulness of radiofrequency ablation (RFA) to achieve a lower percentage of positive margins.
  • To validate clinically the efficacy and safety of the method in breast tumors smaller than < 2 cm.

Specific objectives of the project:

  1. To demonstrate that , after RFA, clear margins are increased in the intraoperative pathological analysis compared to conventional surgery.

    1. To quantify the number of positive margins requiring intraoperative extension in each patient, comparing the ratio in both groups.
    2. To quantify the percentage of patients requiring intraoperative extension compared in both groups.

  2. To demonstrate a reduction in the volume of breast tissue removed after RFA compared to conventional surgery.

    1. Comparing in both groups the anteroposterior, transverse and craniocaudal diameters of the excised specimen, measured in cm, and to calculate the volume.
    2. Tumor weight in grams (including extensions) will be measured to compare the weights in both groups.

  3. To evaluate the differences in cosmetic outcome after RFA versus conventional surgery.

    a. An international scale will be used and the scores will be compared. There will be two independent assessments, one for the physician and another for the patient.

  4. To demonstrate the effectiveness of the RFA by cluster "cool-tip" electrode in the experimental group.

    1. RFA is considered as complete when no viable tumor tissue is evidenced by oxidation-reduction reaction mediated by NADH-diaphorase after surgical resection. Mitochondrial dysfunction will be also evaluated by semiquantitative and quantitative method using the enzyme cytochrome c oxidase or Complex IV (COX) and tunel. Any residual viable tumor tissue will be considered as incomplete RFA.
    2. Risk factors for incomplete ablations will be analyzed, especially tumor vascularization.
  5. To demonstrate the safety of RFA by cluster "cool-tip" electrode in breast cancer tumors a. To quantify all side effects that may occur after the RFA and / or surgery and to correlate the complication rate in each group with severity.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Hospital Universitario 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast single tumor,
  • Clearly visible by ultrasound,
  • Diameter < 2 cm
  • Located >1 cm from the chest wall and skin;
  • Ductal carcinoma according to previous biopsy,
  • < 20% of intraductal carcinoma

Exclusion Criteria:

  • Breast cancer in men;
  • Personal history of ipsilateral breast cancer;
  • Age <40 years;
  • Pregnancy or breastfeeding;
  • Suspicion of intraductal extension or multifocality by mammography or MRI;
  • Tumour not visible by ultrasound;
  • Diameter > 2 cm;
  • Distance to muscle or skin <1 cm;
  • Lobular carcinoma;
  • Intraductal carcinoma in > 20% of the biopsy sample
  • Patients undergoing neoadjuvant chemotherapy or hormonotherapy.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA group
A percutaneous (utlrasound-guided) radiofrequency ablation (RFA) of the tumor will be performed by the radiologist under general anesthesia. Immediately after, excision of the tumor with appropriate margin will be accomplished.
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.
No Intervention: Control group
Normal excision of the tumor according to the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.)
Time Frame: 1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security of RFA (Adverse effects and cosmetic result)
Time Frame: 15 days
Adverse effects and cosmetic result will be evaluated 15 days after the procedure
15 days
Efficacy of RFA (Tumoral viability in the ablation zone)
Time Frame: 7 days
Tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunel
7 days

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 Universitario Bellvitge-Idibell_Universidad de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC133/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Breast Cancer

Clinical Trials on Radiofrequency ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe