Radiofrequency Ablation in Breast Cancer

NCT02281812 | Terminated

• 1 other identifier: AC133/12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Ablation Technique; Breast cancer; Stage 1; Lumpectomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative free margins (distance between the tumor and the margin in order to indicate if extensions are mandatory.)

  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 Outcomes (2)

• Security of RFA (Adverse effects and cosmetic result)

  15 days

• Efficacy of RFA (Tumoral viability in the ablation zone)

  7 days

Study Arms (2)

RFA group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Normal excision of the tumor according to the protocol

Interventions

Radiofrequency ablation PROCEDURE

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.

RFA group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (1)

• Garcia-Tejedor A, Guma A, Soler T, Valdivieso A, Petit A, Contreras N, Chappuis CG, Falo C, Pernas S, Amselem A, Pla MJ, Fernandez-Montoli E, Burdio F, Ponce J. Radiofrequency Ablation Followed by Surgical Excision versus Lumpectomy for Early Stage Breast Cancer: A Randomized Phase II Clinical Trial. Radiology. 2018 Nov;289(2):317-324. doi: 10.1148/radiol.2018180235. Epub 2018 Aug 21.

  PMID: 30129904 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Amparo Garcia-Tejedor, MDPhD

  Hospital Universitario Bellvitge-Idibell_Universidad de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 4, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)