Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Carcinoma, Ductal Adenocarcinoma |
Device: Active Breathing Coordinator |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator |
- Test the efficacy of the ABC device in protecting the heart from radiation damage in patients with L breast cancer. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | October 2017 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
-
Device: Active Breathing Coordinator
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
Contacts and Locations| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Richard Zellars, M.D. | Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00321048 History of Changes |
| Other Study ID Numbers: | J0609, NA_00002394 |
| Study First Received: | May 1, 2006 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
breast cancer SPECT ABC device Invasive adenocarcinoma of the left breast Ductal Carcinoma In Situ of the left breast |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Breast Neoplasms Neoplasms Carcinoma Carcinoma, Ductal Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 21, 2013