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Search / Trial NCT05717998

Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Feb 6, 2023

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how chest radiation therapy, which is used to treat certain types of lung and esophageal cancers, might affect the heart. Researchers want to find early signs of heart damage by using special imaging tests and blood tests. They will look for changes in the heart's structure and function during and shortly after the radiation therapy. The goal is to identify patients who may be at risk for heart problems, which could help doctors develop safer and more effective cancer treatments in the future.

To be eligible for this study, participants need to be adults aged 18 or older who are receiving radiation therapy for lung cancer or esophageal cancer. They should not have any medical conditions that would prevent them from undergoing the imaging tests. Participants can expect to have a few tests that involve specialized imaging techniques to assess their heart health, along with regular check-ups. It's important for potential participants to discuss any concerns with their doctor, especially if they are pregnant or have certain medical conditions.

Gender

ALL

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

About Ohio State University Comprehensive Cancer Center

The Ohio State University Comprehensive Cancer Center (OSUCCC) is a leading institution dedicated to advancing cancer research, treatment, and education. As a National Cancer Institute-designated comprehensive cancer center, OSUCCC integrates cutting-edge research with clinical practice to develop innovative therapies and improve patient outcomes. With a collaborative approach that unites scientists and clinicians, OSUCCC focuses on personalized medicine, cancer prevention, and community outreach, striving to enhance the understanding of cancer biology and provide hope to patients through groundbreaking clinical trials and comprehensive care programs.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Eric D Miller, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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