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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00210223 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Radiofrequency of Breast Cancers in Non Surgical Patients
RF SEIN |
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Scientific title:
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Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00210223 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Fabienne VALENTIN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Bergonié |
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Key inclusion & exclusion criteria
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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
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: Radiofrequency
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Primary Outcome(s)
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- no local recurrence (detected with magnetic resonance imaging)
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- no palpable mass on clinical examination
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To know at 6 months the efficacy of radiofrequency based on
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Secondary Outcome(s)
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- the late complications of the percutaneous technique
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- the pain felt by the patients, during and after the radiofrequency
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To evaluate every 2 months, until 6 months :
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Secondary ID(s)
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RF SEIN
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IB2004-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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