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RecruitingInterventionalPhase 2

The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers

NCT ID: NCT07132918Sponsor: University of Wisconsin, MadisonLast updated: 2026-03-11

Summary

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

Detailed description

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.

Arms & interventions

  • RadiationMRgART

    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.

  • RadiationLINAC

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

Outcome measures

Primary

  • 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

Secondary

  • Change in right ventricular function (RVEF)

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

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

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

  • Change in myocardial strain

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

  • Change in T1 Mapping

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

  • Change in extracellular volume fraction (ECV)

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

  • Change in T2 mapping

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

  • Change in semi-quantitative perfusion

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

  • Change in late gadolinium enhancement

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

  • Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score

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

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

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

  • Toxicity related to cancer

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705

Recruiting
Cancer Connect · Contact
800-622-8922cancerconnect@uwcarbone.wisc.edu
Carri Glide-Hurst, PhD, DABR, FAAPM · Principal Investigator