Evaluating heart damage after chest radiation therapy for cancer

A Pilot Study to Evaluate Early Signs of Myocardial Injury After Thoracic Radiotherapy Using Imaging and Blood-Based Biomarkers

This study is testing if chest radiation therapy for lung and gastroesophageal cancers can cause early heart damage in patients, using advanced imaging and blood tests to spot any problems.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT05717998 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed lung non-small cell carcinoma or gastroesophageal cancer who are scheduled to receive thoracic radiation therapy.

Not a fit: Patients who are not undergoing thoracic radiation therapy or have contraindications to MRI or PET imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify patients at risk for heart issues after radiation therapy, leading to improved monitoring and treatment strategies.

How similar studies have performed: Other studies have shown promising results in assessing cardiac damage post-radiation therapy, but this specific approach combining imaging and blood biomarkers is relatively novel.

Eligibility criteria

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 this trial is running

Columbus, Ohio

• 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

Conditions Lung Non-Small Cell Carcinoma; GastroEsophageal Cancer; Esophagus Cancer