A Phase 2 interventional study of MRgART and LINAC in Non-Small Cell Lung Cancer (Stage III), Esophageal Cancer Stage I-III and Esophagogastric Cancer Stage I-III, sponsored by University of Wisconsin, Madison. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
Funding issues
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:
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with or cytologically proven AJCC, 8th edition including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART)
Radiation: MRgART
Participants randomized to this arm will receive linear accelerator (LINAC) radiation therapy
Radiation: LINAC
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.
Change 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
Plan to share: Yes — De-identified individual participant data (IPD) collected during the study will be shared in accordance with the NIH Data Management and Sharing Policy. Data will be made available to qualified researchers for the purpose of secondary analyses that are consistent with the informed consent provided by participants. The data will be de-identified to protect participant privacy and confidentiality.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be made available no later than 12 months after the primary completion date or upon publication of the primary results, whichever comes first. Data will remain available for a minimum of 5 years
Access criteria: Researchers must submit a data access request that includes a research proposal, data use plan, and institutional review board (IRB) approval or exemption. Access will be granted through a controlled-access repository following review and approval by a data access committee. A Data Use Agreement (DUA) must be signed prior to data release.
No publications or documents are linked to this record.
Funding issues
Funding issues
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
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