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

Last updated: July 1, 2025
Sponsor: Ohio State University Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Digestive System Neoplasms

Treatment

Biospecimen Collection

Magnetic Resonance Imaging of the Heart

Computed Tomography

Clinical Study ID

NCT05717998
OSU-20351
NCI-2021-08714
  • Ages > 18
  • All Genders

Study Summary

This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have been evaluated by a radiation oncologist and have been felt to besuitable to undergo thoracic RT for histologically confirmed NSCLC with a dose rangeof 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stageI-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 Gyat 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 asparticipation in this study does not interfere with activities required in the otherstudies

  • Patients with no contra-indications to magnetic resonance (MR) or PET imaging asstated in the section exclusion criteria

  • For the delayed enhancement and the T1 contrast mapping portions of the study, thepatient must have an adequate baseline renal function defined as an estimatedglomerular filtration rate (eGFR) > 30 ml/min per the Ohio State InstitutionalGuidelines. Of note, if the patient's eGFR is =< 30 ml/min, the patient would stillbe eligible for enrollment, but only the strain-encoded (SENC) imaging and T2mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would notbe included

  • Patients with moderate to end-stage renal disease, or who are at high-risk ofnephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acuterenal failure, chronic kidney disease, and iron overload conditions) would still beeligible for enrollment, but only the non-contrast SENC and T2 mapping imagingsequences would be obtained. The DCE and T1 mapping sequences, which require IVcontrast, would not be included

  • Age >= 18 years old

  • Within 4 weeks of study entry: patients must have vital signs, history/physicalexamination, and kidney function test (eGFR)

  • Ability to provide written informed consent obtained prior to participation in thestudy 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 anacceptable pregnancy assessment

Exclusion

Exclusion Criteria:

  • Subjects who are breast-feeding, or have a positive pregnancy test will be excludedfrom the study. Should a woman become pregnant or suspect she is pregnant whileparticipating 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, nursingmothers, weight greater than 350 pounds)

  • Subjects with advanced renal disease (eGFR < 45 mL/min/1.72m^2) - exclusion fromreceipt of contrast, but may still be enrolled for basic CMR imaging (leftventricular ejection [LVEF], strain, T2, etc)

  • Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weightgreater than 420 pounds - scanner limit)

  • Any serious and/or unstable pre-existing medical disorder (aside from malignancyexception above), psychiatric disorder, or other condition that could preventcompliance with study procedures or providing informed consent

  • Subjects who are prisoners

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Biospecimen Collection
Phase:
Study Start date:
April 02, 2021
Estimated Completion Date:
June 18, 2026

Study Description

PRIMARY OBJECTIVES:

I. To evaluate and quantitate early changes in myocardial fibrosis following thoracic radiation therapy (RT).

II. To assess quantitative early changes in myocardial inflammation after thoracic RT.

III. To determine if thoracic RT is associated with early changes in myocardial metabolism as assessed with cardiac positron emission tomography (PET).

SECONDARY OBJECTIVES:

I. To evaluate and quantitate early changes in subclinical myocardial dysfunction after thoracic RT.

II. To determine if thoracic RT is associated with early changes in myocardial metabolism using alternative cardiac PET-derived biomarkers.

III. To evaluate and quantitate early changes in blood-based biomarkers after thoracic RT.

IV. To assess the incidence and severity of cardiac events following completion of thoracic RT.

OUTLINE:

Within 2 weeks of starting RT, patients undergo cardiac magnetic resonance (CMR) imaging, cardiac positron emission tomography (PET)/computed tomography (CT) and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.

Connect with a study center

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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