Cardiac Effects From Radiation Therapy by MRI

NCT04486573 | Completed DMC

• 2 other identifiers: 20-0537.ccNCI-2020-06349
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Treatment; Cancer; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Change in myocardial strain

  Assess for a change in myocardial strain, as measured by CMRI scans performed before and after RT

  2 years

Secondary Outcomes (10)

• T1 pre- and post-contrast values

  2 years

• Extracellular volume fraction

  2 years

• T2 values

  2 years

• Late gadolinium enhancement

  2 years

• Left ventricular ejection fraction

  2 years

Study Arms (1)

CMRI

OTHER

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

Interventions

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.

CMRI

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• years of age
• KPS ≥ 70 or ECOG ≥ 1
• Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
• Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy

You may not qualify if:

• Previous history of RT to the thorax or breast
• Implanted device that is non-MRI compatible or any implanted device in chest
• 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.
• Found to be pregnant or breast-feeding
• Known history of atrial fibrillation or frequent ventricular or atrial premature beats
• Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate \< 60mL/min)
• History of coronary artery disease or myocardial disease
• History of hypertension, requiring \>1 antihypertensive agent to maintain blood pressure \<140/90
• Known history of valvular stenosis or regurgitation of \> moderate severity
• Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
• Systolic blood pressure \< 90mmGy
• Pulse \< 50/minute
• Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
• Suspicion or diagnosis of amyloidosis
• Suspicion or diagnosis of hemochromatosis

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Sarah Milgrom, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 24, 2020
• Study Start: July 15, 2020
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)