Breast Cancer
Conditions
Brief 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
Interventions
PROCEDUREThermic destruction of tissue by Laser using the Novilase device
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of laser treatment | 28 days after initial diagnosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Life quality | D-0 and before the surgery | Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3 |
Countries
France
Outcome results
None listed