Trials / Completed
CompletedNCT00882596
Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to "Low-risk" Breast Cancer Patients
A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Cancer Center of Irvine · Academic / Other
- Sex
- Female
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.
Detailed description
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Accelerated partial breast irradiation | A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2013-05-01
- Completion
- 2013-07-01
- First posted
- 2009-04-16
- Last updated
- 2018-01-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00882596. Inclusion in this directory is not an endorsement.