Recruiting

Brachytherapy Devices

Sponsor:

St. Vincent's Medical Center

Code:

NCT01813825

Conditions

This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Registry

Study Details

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. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.

The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.

Conditions

This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting.

Study ID

NCT01813825

Start date

Nov, 2004

Status verified date

Mar, 2013

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Female >=45 years, negative margins, DCIS

Interventions

Registry

Primary outcome measure

  • A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities [ Time Frame: 1-4 weeks ]

Central Contacts and Locations

Central contacts

Deborah Fang, MD

203-576-5085

Locations

St. Vincent's Medical Center

Recruiting

Bridgeport, Connecticut, United States, 06606

Principal Investigator:

Deborah Fang, MD

More Information

Sponsor

St. Vincent's Medical Center

Last update posted

Mar 19, 2013

Last verified

Mar, 2013

Keywords

  • Mammosite

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Vincent's Medical Center on 2013-03-19.