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Radiofrequency of Breast Cancers in Non Surgical Patients (RF SEIN)

This study has been completed.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210223
First received: September 13, 2005
Last updated: December 29, 2011
Last verified: October 2007
History of Changes
  Purpose

To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation


Condition Intervention
Breast Cancer
 Procedure: Radiofrequency

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • To know at 6 months the efficacy of radiofrequency based on
  • - no local recurrence (detected with magnetic resonance imaging)
  • - no palpable mass on clinical examination

Secondary Outcome Measures:
  • To evaluate every 2 months, until 6 months :
  • - the late complications of the percutaneous technique
  • - the pain felt by the patients, during and after the radiofrequency

Estimated Enrollment: 10
Study Start Date: April 2004
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210223

Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Fabienne VALENTIN, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210223     History of Changes
Other Study ID Numbers: IB2004-16, RF SEIN
Study First Received: September 13, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Radiofrequency
Percutaneous technique
breast cancer
tolerance

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

ClinicalTrials.gov processed this record on May 19, 2013