Trial Information
Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients
Inclusion Criteria
Inclusion criteria:
- Patients more than 70 years old
- Breast tumors with estrogen receptors
- Non surgical patients
- Life expectancy more than 6 months
Exclusion criteria:
- Presence of a pace maker
- Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm
from skin, nipple, or pectoral muscle
- Coagulation disorders
- Contra indications to magnetic resonance imaging or computed tomography with contrast
medium injection
- Non visible lesions on magnetic resonance imaging or computed tomography with
contrast medium injection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To know at 6 months the efficacy of radiofrequency based on
Principal Investigator
Fabienne VALENTIN, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Bergonié
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IB2004-16
NCT ID:
NCT00210223
Start Date:
April 2004
Completion Date:
July 2006
Related Keywords:
- Breast Cancer
- Radiofrequency
- Percutaneous technique
- breast cancer
- tolerance
- Breast Neoplasms