Clinical trial · Interventional
Local Treatment by Thermic Destruction of Primitive Breast Cancer
Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.
NCT01706016CI-TRIAL-00032273LASERBREAST1completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermic destruction of tissue by Laser using the Novilase device | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with breast cancer smaller than 20mm
- interventionNames
- Procedure: Thermic destruction of tissue by Laser using the Novilase device
Primary outcomes (1)
- measure
- Effectiveness of laser treatment
- timeFrame
- 28 days after initial diagnosis
- description
- 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 outcomes (1)
- measure
- Life quality
- timeFrame
- D-0 and before the surgery
- description
- Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.