Pilot Study of Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy
Completed
Conditions studied: Breast Cancer
In brief
Patients with breast cancer receive low doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy. Indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold. The investigators wish to develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects. These patients can then be targeted for close monitoring and early intervention, potentially with statins or ACE inhibitors. Additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to radiotherapy (RT) field design for patients sensitive to RT effects. Finally, this information can be incorporated into better designs of treatment plans for future patients.
Key facts
- Study ID
- NCT02494453
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 23
- Starts
- 2015-06-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2019-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who will receive radiotherapy as treatment for left-sided breast cancer
- Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.
You may not qualify if…
- Patients with a contraindication to contrast-enhanced MRI
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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