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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210223
First Posted: September 21, 2005
Last Update Posted: July 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut Bergonié
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00210223     History of Changes
Other Study ID Numbers: IB2004-16
RF SEIN
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: July 26, 2013
Last Verified: October 2007

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