Status:
COMPLETED
Cardiac Effects From Radiation Therapy by MRI
Lead Sponsor:
University of Colorado, Denver
Conditions:
Radiation Treatment
Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy, and the treating radiation oncologist anticipates a mean left v...
Detailed Description
Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after radiation exposure...
Eligibility Criteria
Inclusion
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- 18 - 100 years of age
- KPS ≥ 70 or ECOG ≥ 1
- Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
- Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy
Exclusion
- Previous history of RT to the thorax or breast
- Implanted device that is non-MRI compatible or any implanted device in chest
- Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating.
- Found to be pregnant or breast-feeding
- Known history of atrial fibrillation or frequent ventricular or atrial premature beats
- Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate \< 60mL/min)
- History of coronary artery disease or myocardial disease
- History of hypertension, requiring \>1 antihypertensive agent to maintain blood pressure \<140/90
- Known history of valvular stenosis or regurgitation of \> moderate severity
- Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
- Systolic blood pressure \< 90mmGy
- Pulse \< 50/minute
- Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
- Suspicion or diagnosis of amyloidosis
- Suspicion or diagnosis of hemochromatosis
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04486573
Start Date
July 15 2020
End Date
September 14 2023
Last Update
October 22 2024
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045