The goal of this clinical trial is to compare a new way of using magnetic resonance-guided adaptive radiation therapy (MRgART) to the standard of care linear accelerator (LINAC) radiation treatment in people with cancer in the thoracic region near the heart. The main question it aims to answer is whether MRgART affects the heart differently than LINAC. Participants will: * Receive radiation therapy * Undergo MRIs and bloodwork * Complete quality of life questionnaires
This clinical trial, The cARdiac Radiation Therapy Sparing (HEARTS) trial, will compare MR-guided adaptive radiation therapy (MRgART) with substructure sparing to standard of care x-ray based linac RT with whole-heart dose metrics for patients with cancer in the thoracic region based on longitudinal changes in cardiac function using MRI, quality of life, cardiac waveforms, and blood biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Magnetic Resonance-guided Adaptive Radiation Therapy (MRgART) is a form of MRgRT that incorporates daily adaptive planning, or making a new treatment plan each treatment, and real-time imaging during treatment delivery.
Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.
University of Wisconsin - Madison
Madison, Wisconsin, United States
RECRUITINGChange in left ventricular ejection fraction (LVEF)
Changes are measured between timepoints as determined by cardiac MRI. LVEF is calculated by dividing the left ventricular (LV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the left ventricle before contraction) and multiplying by 100.
Time frame: Pre-treatment, 3 months post-treatment, 6 months post-treatment
Change in right ventricular function (RVEF)
Changes are measured between timepoints as determined by cardiac MRI. RVEF is calculated by dividing the right ventricular (RV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the right ventricle before contraction) and multiplying by 100.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in left and right ventricular (LV/RV) volumes
Volumes of LV and RV chamber - each derived from tracing the endocardial borders at end-diastole and end-systole in a cardiac MRI scan.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in myocardial strain
Myocardial strain measures how much the heart muscle stretches or contracts during a heartbeat. Strain is measured on cardiac MRI images by tracking myocardial deformation using feature tracking techniques, which analyze changes in myocardial length or orientation between end-diastole and end-systole to calculate strain values.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in T1 Mapping
By acquiring a series of images at different inversion times (Modified Look-Locker Inversion recovery sequence), the longitudinal relaxation time of myocardial tissue on a pixel-by-pixel basis to derive the T1 map.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in extracellular volume fraction (ECV)
Extracellular volume fraction (ECV) is measured in cardiac MRI by first acquiring T1 maps of the heart before and after administering a gadolinium-based contrast agent, then using the change in T1 values of both the myocardium and blood pool-along with the patient's hematocrit-to calculate the proportion of the heart tissue made up of extracellular space.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in T2 mapping
T2 maps are derived by acquiring images at multiple echo times using a T2-prepared sequence and analyzed.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in semi-quantitative perfusion
Semi-quantitative perfusion analysis in cardiac MRI is used to assess myocardial blood flow by analyzing the dynamic passage of contrast agent through the heart muscle. The process involves acquiring first-pass contrast-enhanced images, defining myocardial and blood pool contours, segmenting the myocardium, and generating signal intensity curves to extract parameters such as upslope and time to peak-providing insight into regional perfusion
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change in late gadolinium enhancement
Late gadolinium enhancement (LGE) in cardiac MRI is measured by acquiring inversion recovery images post-contrast, nulling normal myocardium, and quantifying enhancing regions using signal intensity thresholds relative to remote myocardium to assess myocardial scar or fibrosis.
Time frame: Pre-treatment, 3 months, 6 months post-treatment
Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score
Using the abbreviated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) quality of life will be measured. The KCCQ-12 is a heart failure-specific health status measure that provides scores for physical limitation, symptom frequency, quality of life, and social limitation. Scores range from 0 to 100, with higher scores indicating better health. Ranges like "very poor to poor" (0-24), "poor to fair" (25-49), "fair to good" (50-74), and "good to excellent" (75-100), can add further categorization.
Time frame: Baseline to 12 months post-treatment (up to 14 months)
Change in Functional Assessment of Cancer Therapy - Lung (FACT-L) Score
The FACT-L Scale is a 36-item self-report instrument that measures multidimensional quality of life. It is scored on a 5-point Likert scale ranging from 0-4, with 0 = not at all and 4 = very much. Scores range from 0-144 where higher scores indicate greater quality of life.
Time frame: Baseline to 12 months post-treatment (up to 14 months)
Toxicity related to cancer
Toxicity will be measured by number of adverse events
Time frame: Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment
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