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Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1)

This study is currently recruiting participants.
Verified October 2012 by Institut Gustave Roussy
Sponsor:
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT01706016
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser


Condition Intervention Phase
Breast Cancer
 Procedure: Thermic destruction of tissue by Laser using the Novilase device
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Effectiveness of laser treatment [ Time Frame: 28 days after initial diagnosis ] [ Designated as safety issue: No ]

    Destruction of the carcinoma will be assess by histological analysis of the specimen.

    If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail



Secondary Outcome Measures:
  • Life quality [ Time Frame: D-0 and before the surgery ] [ Designated as safety issue: No ]
    Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Noninflammatory unilateral and unifocal breast cancer
  • Size </= 20mm (ultrasound measure)
  • Histological confirmation of cancer by biopsy grade status hormone and HER2.
  • Good delineation of the lesion on ultrasound.
  • Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
  • Age between 18 and 80
  • ECOG performance status 0 or 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706016

Contacts
Contact: Jean Remy GARBAY, MD +33 1 42 11 43 50 garbay@igr.fr
Contact: Ariane DUNANT +33 1 42 11 53 89 adunant@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Jean Remy GARBAY, MD     +33 1 42 11 43 50     garbay@igr.fr    
Principal Investigator: Jean Remy GARBAY, MD            
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Jean Remy GARBAY, MD Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT01706016     History of Changes
Other Study ID Numbers: 2012-A00448-35, 2011/1773
Study First Received: October 10, 2012
Last Updated: October 12, 2012
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013