Status:
UNKNOWN
A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
Lead Sponsor:
St. Vincent's Medical Center
Conditions:
This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.
Eligibility:
FEMALE
45+ years
Brief Summary
A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Re...
Detailed Description
PURPOSE OF STUDY The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approve...
Eligibility Criteria
Inclusion
- Be 45 years of age or older
- Be a Tis, T1, N0 M0 - American Joint Committee Classification
- Have negative surgical margins (NSABP definition) after final surgery
- Should have adequate skin spacing between balloon surface and surface of the skin (\>=7mm)
- DCIS
Exclusion
- Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)
- Have collagen-vascular disease
- Have extensive intraductal component (Harvard Definition,\>25% DCIS)
- Have infiltrating lobular histology
Key Trial Info
Start Date :
November 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01813825
Start Date
November 1 2004
End Date
December 1 2015
Last Update
March 19 2013
Active Locations (1)
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1
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606