MR-guided heart-sparing radiation for cancers near the heart
The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers
This trial will test whether MR-guided adaptive radiation that spares parts of the heart causes different heart effects than standard LINAC radiation in adults receiving daily radiation for cancers in the chest.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07132918 on ClinicalTrials.gov |
What this trial studies
HEARTS is a phase 2 interventional comparison of MR-guided adaptive radiation therapy (MRgART) with substructure sparing versus standard x-ray LINAC radiation using whole-heart dose metrics for patients with thoracic-region cancers. Eligible participants must meet dosimetric criteria (e.g., >10% of the heart receiving >25 Gy by rapid auto-planning) and have a planned course of daily fractionated RT typically of at least 15 fractions. Participants receive either MRgART or standard LINAC RT and are followed with serial cardiac MRI, blood biomarker testing, cardiac waveform monitoring, and quality-of-life questionnaires to measure longitudinal changes in cardiac function. Treatment planning is guided by QUANTEC-based endpoints, and the trial is conducted at the University of Wisconsin–Madison in collaboration with the NHLBI.
Who should consider this trial
Good fit: Adults (age >18) with thoracic-region cancers (for example certain stages of non-small cell lung, esophageal, esophagogastric, thymic cancers, or other thoracic tumors) who meet the dosimetric eligibility and are planned for a daily fractionated RT course of at least 15 fractions are ideal candidates.
Not a fit: Patients with limited life expectancy from metastatic disease (<12 months), those who do not meet the dosimetric or fractionation requirements (including regimens with twice-daily fractions excluded), or those unable to undergo the required imaging and monitoring are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce radiation-related heart injury and help preserve cardiac function in patients receiving chest radiation.
How similar studies have performed: MR-guided adaptive radiation has shown promise in reducing dose to nearby organs in other tumor sites, but direct evidence for heart-sparing in thoracic cancers remains limited and is an active area of research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madison, Wisconsin
- University of Wisconsin - Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Carri Glide-Hurst, PhD, DABR, FAAPM — University of Wisconsin, Madison
- Study coordinator: Cancer Connect
- Email: cancerconnect@uwcarbone.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.