Clinical trial · Observational
A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting. | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Registry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Female >=45 years, negative margins, DCIS
- interventionNames
- Other: Registry
Primary outcomes (1)
- measure
- A Single Site Prospective, Non Randomized Study of Partial Breast Intracavitary Brachytherapy Devices To Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
- timeFrame
- 1-4 weeks
- description
- The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available