NCT00321048

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

Detailed description

50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. After the completion of radiation therapy, patients will be seen on the following schedule: A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy. Patients must be 18 and older and must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. Patients must have also undergone a segmental mastectomy (SM) or Mastectomy. Patients must not have received prior radiation therapy to the breast at any time for any reason. Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.

Conditions

• Breast Neoplasms
• Carcinoma, Ductal
• Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Active Breathing Coordinator	A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2006-05-03
• Last updated: 2025-02-28
• Results posted: 2019-06-19

Locations

1 site across 1 country: United States