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

This study has been completed.
Information provided by:
Institut Bergonié Identifier:
First received: September 13, 2005
Last updated: July 25, 2013
Last verified: October 2007
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:

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

Enrollment: 15
Study Start Date: April 2004
Study Completion Date: July 2006

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00210223

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

No publications provided Identifier: NCT00210223     History of Changes
Other Study ID Numbers: IB2004-16, RF SEIN
Study First Received: September 13, 2005
Last Updated: July 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Percutaneous technique
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on November 27, 2015