Radiofrequency of Breast Cancers in Non Surgical Patients

Breast Cancer Clinical Trial

— RF SEIN  

Official title:

Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210223
• Other study ID #: IB2004-16
• Secondary ID: RF SEIN
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 25, 2013
• Start date: April 2004
• Est. completion date: July 2006

Study information

• Verified date: October 2007
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Radiofrequency

Locations

Country	Name	City	State
France	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To know at 6 months the efficacy of radiofrequency based on
Primary	- no local recurrence (detected with magnetic resonance imaging)
Primary	- no palpable mass on clinical examination
Secondary	To evaluate every 2 months, until 6 months :
Secondary	- the late complications of the percutaneous technique
Secondary	- the pain felt by the patients, during and after the radiofrequency