Trials / Completed
CompletedNCT00328783
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Detailed description
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active Breathing Coordinator (ABC) | The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. |
| RADIATION | Radiation Therapy |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2006-05-22
- Last updated
- 2025-04-30
- Results posted
- 2014-04-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00328783. Inclusion in this directory is not an endorsement.