Non-Small Cell Lung Cancer (Stage III)Phase 2NCT07132918
HEARTS Trial for Thoracic Cancers
A Phase 2 study testing MRgART and LINAC in people with Non-Small Cell Lung Cancer (Stage III) and Esophageal Cancer Stage I-III, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (Stage III), Esophageal Cancer Stage I-III, Esophagogastric Cancer Stage I-III
- What is being tested?
- MRgART and LINAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Cancer Connect, 800-622-8922, cancerconnect@uwcarbone.wisc.edu
Carri Glide-Hurst, PhD, DABR, FAAPM
About this study
Official title: The cARdiac Radiation Therapy Sparing (HEARTS) 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
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer (Stage III), Esophageal Cancer Stage I-III, Esophagogastric Cancer Stage I-III, Thymoma and Thymic Carcinoma Stage II-III, Other Cancers in the Thoracic Region
- Being tested
- MRgART, LINAC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgARTRadiation
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.
LINACRadiation
Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.
| Study group | Role | What they receive |
|---|---|---|
| MRgART radiation therapy | Experimental | Participants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART) Receives: Radiation: MRgART |
| LINAC radiation therapy | Experimental | Participants randomized to this arm will receive linear accelerator (LINAC) radiation therapy Receives: Radiation: LINAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment, 3 months post-treatment, 6 months post-treatment
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months post-treatment (up to 14 months)
Toxicity related to cancer
Toxicity will be measured by number of adverse events
Measured: Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start8 Oct 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (Stage III)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carri Glide-Hurst, PhD, DABR, FAAPM, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132918
- Sponsor's protocol ID
- 2025-0798
- Other IDs
- 5R01HL153720-03, A533300, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, Protocol Version 1/20/2026
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers
- ClinicalTrials.gov ID
- NCT07132918
- Acronym / sponsor ID
- 2025-0798
- Conditions
- Non-Small Cell Lung Cancer (Stage III), Esophageal Cancer Stage I-III, Esophagogastric Cancer Stage I-III, Thymoma and Thymic Carcinoma Stage II-III, Other Cancers in the Thoracic Region
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRgART radiation therapy | Experimental | Radiation: MRgARTParticipants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART) |
| LINAC radiation therapy | Experimental | Radiation: LINACParticipants randomized to this arm will receive linear accelerator (LINAC) radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRgARTMagnetic 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 | MRgART radiation therapy |
| LINACDaily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement. | Radiation | LINAC radiation therapy |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carri Glide-Hurst, PhD, DABR, FAAPM principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRgART and LINAC in people with Non-Small Cell Lung Cancer (Stage III) and Esophageal Cancer Stage I-III, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, cancerconnect@uwcarbone.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (LVEF) (time frame: Pre-treatment, 3 months post-treatment, 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.