Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy
NCT ID: NCT05717998
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
28 participants
OBSERVATIONAL
2021-04-02
2026-06-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ancillary-correlative (CMR, PET/CT, biospecimen collection)
Within 2 weeks of starting RT, patients undergo CMR, cardiac PET/CT and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo cardiac PET/CT
Magnetic Resonance Imaging of the Heart
Undergo CMR
Positron Emission Tomography
Undergo cardiac PET/CT
Interventions
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Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo cardiac PET/CT
Magnetic Resonance Imaging of the Heart
Undergo CMR
Positron Emission Tomography
Undergo cardiac PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Eric Miller
Principal Investigator
Principal Investigators
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Eric D Miller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2021-08714
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-20351
Identifier Type: -
Identifier Source: org_study_id
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