HEARTS Trial for Thoracic Cancers
The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers
5 other identifiers
interventional
60
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
August 20, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
March 11, 2026
March 1, 2026
3.4 years
August 12, 2025
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Pre-treatment, 3 months post-treatment, 6 months post-treatment
Secondary Outcomes (11)
Change in right ventricular function (RVEF)
Pre-treatment, 3 months, 6 months post-treatment
Change in left and right ventricular (LV/RV) volumes
Pre-treatment, 3 months, 6 months post-treatment
Change in myocardial strain
Pre-treatment, 3 months, 6 months post-treatment
Change in T1 Mapping
Pre-treatment, 3 months, 6 months post-treatment
Change in extracellular volume fraction (ECV)
Pre-treatment, 3 months, 6 months post-treatment
- +6 more secondary outcomes
Study Arms (2)
MRgART radiation therapy
EXPERIMENTALParticipants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART)
LINAC radiation therapy
EXPERIMENTALParticipants randomized to this arm will receive linear accelerator (LINAC) radiation therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carri Glide-Hurst, PhD, DABR, FAAPM
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
August 20, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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.