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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06349 | Other Identifier | CTRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMRI | Other | Clinical data will be collected regarding cardiac risk factors, cancer type, and cancer treatment. CMRI will be performed:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Magnetic Resonance Imaging | Diagnostic Test | A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in myocardial strain | Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| T1 pre- and post-contrast values | Measured by scans performed before and after RT | 2 years |
| Extracellular volume fraction | Measured by scans performed before and after RT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Milgrom, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2 years |
| T2 values | Measured by scans performed before and after RT | 2 years |
| Late gadolinium enhancement | Measured by scans performed before and after RT | 2 years |
| Left ventricular ejection fraction | Measured by scans performed before and after RT | 2 years |
| End diastolic volume | Measured by scans performed before and after RT | 2 years |
| End systolic volume | Measured by scans performed before and after RT | 2 years |
| Left atrial volume | Measured by scans performed before and after RT | 2 years |
| Wall thickness | Measured by scans performed before and after RT | 2 years |
| Left ventricular mass index | Measured by scans performed before and after RT | 2 years |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |