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NCT Number: NCT07132918

HEARTS Trial for Thoracic Cancers

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

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Key information

Conditions

Non-Small Cell Lung Cancer (Stage III) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Stage I-III Esophageal Diseases Esophageal Neoplasms Esophagogastric Cancer Stage I-III Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hemic and Lymphatic Diseases Lung Diseases Lung Neoplasms Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Other Cancers in the Thoracic Region Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thymoma Thymoma and Thymic Carcinoma Stage II-III Thymus Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Cancer Connect

CONTACT

[email protected]

800-622-8922

Carri Glide-Hurst, PhD, DABR, FAAPM

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years at the time of consent.
  • Dosimetric eligibility criteria met using endpoints from QUANTEC (>10% of heart receives > 25 Gy) as determined through rapid auto-planning
  • Participants with histologically or cytologically proven AJCC, 8th edition including:
  • Stage IIB, IIIA, IIIB, IIIC, or IV non-operable non-small cell lung cancer
  • Limited stage small cell lung cancer, once daily treatment (excluding twice per day fractionation schemes). Stage I-III N0-2 disease esophageal/esophagogastric cancer
  • Stage II or III thymoma/thymic carcinoma
  • Other cancers in the thoracic region that meet the dosimetric and other clinical trial criteria, for example lymphoma sarcoma.
  • Participants must have a course of daily fractionated RT planned of at least 15 treatment fractions, typically ranging from 1.8 to 4 Gy/fraction

Exclusion criteria

  • Definitive clinical or radiologic evidence of metastatic disease with life expectancy <12 months
  • Prior thoracic radiotherapy significantly overlapping the heart region
  • Contraindications to MRI
  • Severe, active co-morbidity defined as follows: New York Heart Association Functional Classification III/IV are not eligible.

Treatment and study plan

MRgART

Radiation

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.

Linac

Radiation

Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.

Primary outcomes

  1. Change in left ventricular ejection fraction (LVEF)

    Time frame: Pre-treatment, 3 months post-treatment, 6 months post-treatment

    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.

Secondary outcomes

  1. Change in right ventricular function (RVEF)

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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.

  2. Change in left and right ventricular (LV/RV) volumes

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    Volumes of LV and RV chamber - each derived from tracing the endocardial borders at end-diastole and end-systole in a cardiac MRI scan.

  3. Change in myocardial strain

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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.

  4. Change in T1 Mapping

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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.

  5. Change in extracellular volume fraction (ECV)

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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.

  6. Change in T2 mapping

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    T2 maps are derived by acquiring images at multiple echo times using a T2-prepared sequence and analyzed.

  7. Change in semi-quantitative perfusion

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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

  8. Change in late gadolinium enhancement

    Time frame: Pre-treatment, 3 months, 6 months post-treatment

    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.

  9. Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score

    Time frame: Baseline to 12 months post-treatment (up to 14 months)

    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.

  10. Change in Functional Assessment of Cancer Therapy - Lung (FACT-L) Score

    Time frame: Baseline to 12 months post-treatment (up to 14 months)

    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.

  11. Toxicity related to cancer

    Time frame: Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment

    Toxicity will be measured by number of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Connect

CONTACT

[email protected]

800-622-8922

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 20, 2025
Registry last updated
Mar 11, 2026

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.

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