Evaluating heart damage after chest radiation therapy for cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates early signs of myocardial injury in patients undergoing thoracic radiation therapy for lung non-small cell carcinoma and gastroesophageal cancers. It employs advanced imaging techniques, including cardiac magnetic resonance imaging and positron emission tomography, alongside blood biomarker analysis to detect changes in heart structure, function, and metabolism. The study aims to identify patients at risk for cardiac complications, potentially leading to safer cancer treatment strategies in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have been evaluated by a radiation oncologist and have been felt to be suitable to undergo thoracic RT for histologically confirmed NSCLC with a dose range of 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stage I-IVA (AJCC 8th ed) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) with a planned dose range of 41.4-60 Gy at 1.8-2 Gy per fraction as part of treatment of their malignancy
* Concurrent chemotherapy is permitted
* For NSCLC patients, both concurrent and/or adjuvant immunotherapy is permitted
* Patients participating in other research studies are eligible as long as participation in this study does not interfere with activities required in the other studies
* Patients with no contra-indications to magnetic resonance (MR) or PET imaging as stated in the section exclusion criteria
* For the delayed enhancement and the T1 contrast mapping portions of the study, the patient must have an adequate baseline renal function defined as an estimated glomerular filtration rate (eGFR) \> 30 ml/min per the Ohio State Institutional Guidelines. Of note, if the patient's eGFR is =\< 30 ml/min, the patient would still be eligible for enrollment, but only the strain-encoded (SENC) imaging and T2 mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would not be included
* Patients with moderate to end-stage renal disease, or who are at high-risk of nephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acute renal failure, chronic kidney disease, and iron overload conditions) would still be eligible for enrollment, but only the non-contrast SENC and T2 mapping imaging sequences would be obtained. The DCE and T1 mapping sequences, which require IV contrast, would not be included
* Age \>= 18 years old
* Within 4 weeks of study entry: patients must have vital signs, history/physical examination, and kidney function test (eGFR)
* Ability to provide written informed consent obtained prior to participation in the study and any study specific procedures being performed
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the study entry. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment

Exclusion Criteria:

* Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Medical contraindications to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
* Subjects with advanced renal disease (eGFR \< 45 mL/min/1.72m\^2) - exclusion from receipt of contrast, but may still be enrolled for basic CMR imaging (left ventricular ejection \[LVEF\], strain, T2, etc)
* Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds - scanner limit)
* Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other condition that could prevent compliance with study procedures or providing informed consent
* Subjects who are prisoners

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Eric D Miller, MD, PhD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.