Status:
COMPLETED
Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Breast Cancer Research Foundation
Conditions:
Breast Neoplasms
Carcinoma, Ductal
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- Patient must be 18 and older
- Patients must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.
- Patients must have undergone a segmental mastectomy (SM) or Mastectomy
- Patients must not have received prior radiation therapy to the breast at any time for any reason.
- Any patient with active local-regional disease prior to registration is not eligible.
- Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy.
- Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00321048
Start Date
June 1 2006
End Date
January 1 2010
Last Update
February 28 2025
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205