Cardiac Effects From Radiation Therapy by MRI

Cancer Clinical Trial

Official title:

Identification of Early Cardiac Injury From Radiation Therapy Using Cardiac Magnetic Resonance Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04486573
• Other study ID #: 20-0537.cc
• Secondary ID: NCI-2020-06349
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: March 2025
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiotoxicity
• Radiation Treatment

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial strain	Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT	2 years
Secondary	T1 pre- and post-contrast values	Measured by scans performed before and after RT	2 years
Secondary	Extracellular volume fraction	Measured by scans performed before and after RT	2 years
Secondary	T2 values	Measured by scans performed before and after RT	2 years
Secondary	Late gadolinium enhancement	Measured by scans performed before and after RT	2 years
Secondary	Left ventricular ejection fraction	Measured by scans performed before and after RT	2 years
Secondary	End diastolic volume	Measured by scans performed before and after RT	2 years
Secondary	End systolic volume	Measured by scans performed before and after RT	2 years
Secondary	Left atrial volume	Measured by scans performed before and after RT	2 years
Secondary	Wall thickness	Measured by scans performed before and after RT	2 years
Secondary	Left ventricular mass index	Measured by scans performed before and after RT	2 years