Cardiac Effects From Radiation Therapy by MRI

NCT ID: NCT04486573

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2023-09-14

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.

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.

Conditions

Radiation Treatment; Cancer; Cardiotoxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Cardiac Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_TEST

A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Milgrom, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

NCI-2020-06349

Identifier Type: OTHER

Identifier Source: secondary_id

20-0537.cc

Identifier Type: -

Identifier Source: org_study_id