Clinical trial · Interventional
Cardiac Effects From Radiation Therapy by MRI
Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiotoxicity | — | UNRESOLVED | — |
| Radiation Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac Magnetic Resonance Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CMRI
- description
- 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.
- interventionNames
- Diagnostic Test: Cardiac Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Change in myocardial strain
- timeFrame
- 2 years
- description
- Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. 18 - 100 years of age 4. KPS ≥ 70 or ECOG ≥ 1 5. Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart 6. 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: 1. Previous history of RT to the thorax or breast 2. Implanted device that is non-MRI compatible or any implanted device in chest 3. 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. 4. Found to be pregnant or breast-feeding 5. Known history of atrial fibrillation or frequent ventricular or atrial premature beats 6. Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate \< 60mL/min) 7. History of coronary artery disease or myocardial disease 8. History of hypertension, requiring \>1 antihypertensive agent to maintain blood pressure \<140/90 9. Known history of valvular stenosis or regurgitation of \> moderate severity 10. Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A) 11. Systolic blood pressure \< 90mmGy 12. Pulse \< 50/minute 13. Known history of pulmonary hypertension or elevated right ventricular systolic pressures. 14. Suspicion or diagnosis of amyloidosis 15. Suspicion or diagnosis of hemochromatosis
References
Publications (0)
Data not yet available