NCT07132918 · University of Wisconsin, Madison
HEARTS Trial for Thoracic Cancers
What this study is about
The goal of this clinical trial is to compare a new way of using magnetic resonance-guided adaptive radiation therapy (MRgART) to the the usual treatment 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.
View original scientific description
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.
Interventions
RADIATION
MRgART
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.
RADIATION
LINAC
Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Madison, Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations