Clinical Trials Directory

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

TypeNameDescription
DEVICEActive 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.
RADIATIONRadiation 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.