Skip to main content
OpenTrials
Completed

NCT Number: NCT04486573

Cardiac Effects From Radiation Therapy by MRI

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 18 - 100 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in myocardial strain

    Time frame: 2 years

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

Secondary outcomes

  1. T1 pre- and post-contrast values

    Time frame: 2 years

    Measured by scans performed before and after RT

  2. Extracellular volume fraction

    Time frame: 2 years

    Measured by scans performed before and after RT

  3. T2 values

    Time frame: 2 years

    Measured by scans performed before and after RT

  4. Late gadolinium enhancement

    Time frame: 2 years

    Measured by scans performed before and after RT

  5. Left ventricular ejection fraction

    Time frame: 2 years

    Measured by scans performed before and after RT

  6. End diastolic volume

    Time frame: 2 years

    Measured by scans performed before and after RT

  7. End systolic volume

    Time frame: 2 years

    Measured by scans performed before and after RT

  8. Left atrial volume

    Time frame: 2 years

    Measured by scans performed before and after RT

  9. Wall thickness

    Time frame: 2 years

    Measured by scans performed before and after RT

  10. Left ventricular mass index

    Time frame: 2 years

    Measured by scans performed before and after RT

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2020
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.