Local Treatment by Thermic Destruction of Primitive Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Thermic destruction of tissue by Laser using the Novilase device
Type: Procedure
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Noninflammatory unilateral and unifocal breast cancer

- Size
- 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
Location
Institut Gustave Roussy
Villejuif, Val de Marne, France
Status: Recruiting
Contact: Jean Remy GARBAY, MD - +33 1 42 11 43 50 - garbay@igr.fr
Start Date
October 2012
Completion Date
March 2014
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Source
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page