Cardiac Effects From Radiation Therapy by MRI
Study Details
Study Description
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 ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to identify changes related to radiation exposure. Our primary endpoint will be changes in myocardial strain. Secondary endpoints will include other CMRI parameters.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. Emerging clinical data show that subclinical injury can be identified immediately after treatment. Early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity. The investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early cardiac injury after RT and that imaging changes will be associated regionally with cardiac radiation dose.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: CMRI Clinical data will be collected regarding cardiac risk factors, cancer type, and cancer treatment. CMRI will be performed: Within 2 weeks before the first fraction of radiation therapy (RT) Within 1 week of the final fraction of RT (before or after) Any patient with a pre-RT and post-RT MRI scan will be considered evaluable. Pre- and post-RT CMRI parameters will be compared. 3D reconstructed CMR images will be co-registered with RT treatment plans to assess for spatial associations. |
Diagnostic Test: Cardiac Magnetic Resonance Imaging
A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.
|
Outcome Measures
Primary Outcome Measures
- Change in myocardial strain [2 years]
Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
Secondary Outcome Measures
- T1 pre- and post-contrast values [2 years]
Measured by scans performed before and after RT
- Extracellular volume fraction [2 years]
Measured by scans performed before and after RT
- T2 values [2 years]
Measured by scans performed before and after RT
- Late gadolinium enhancement [2 years]
Measured by scans performed before and after RT
- Left ventricular ejection fraction [2 years]
Measured by scans performed before and after RT
- End diastolic volume [2 years]
Measured by scans performed before and after RT
- End systolic volume [2 years]
Measured by scans performed before and after RT
- Left atrial volume [2 years]
Measured by scans performed before and after RT
- Wall thickness [2 years]
Measured by scans performed before and after RT
- Left ventricular mass index [2 years]
Measured by scans performed before and after RT
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision to sign and date the consent form.
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Stated willingness to comply with all study procedures and be available for the duration of the study.
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18 - 100 years of age
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KPS ≥ 70 or ECOG ≥ 1
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Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
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Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy
Exclusion Criteria:
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Previous history of RT to the thorax or breast
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Implanted device that is non-MRI compatible or any implanted device in chest
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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.
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Found to be pregnant or breast-feeding
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Known history of atrial fibrillation or frequent ventricular or atrial premature beats
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Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate < 60mL/min)
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History of coronary artery disease or myocardial disease
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History of hypertension, requiring >1 antihypertensive agent to maintain blood pressure <140/90
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Known history of valvular stenosis or regurgitation of > moderate severity
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Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
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Systolic blood pressure < 90mmGy
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Pulse < 50/minute
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Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
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Suspicion or diagnosis of amyloidosis
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Suspicion or diagnosis of hemochromatosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Sarah Milgrom, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-0537.cc
- P30CA046934