Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy
A Pilot Study to Evaluate Early Signs of Myocardial Injury After Thoracic Radiotherapy Using Imaging and Blood-Based Biomarkers
2 other identifiers
observational
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2021
CompletedFirst Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 18, 2026
January 2, 2026
December 1, 2025
5.2 years
September 2, 2021
December 27, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in extracellular volume (ECV)
To identify the presence of cardiac fibrosis as assessed by cardiac magnetic resonance-derived ECV during and shortly after RT.
Baseline up to 6 months post-radiation therapy (RT)
Changes in myocardial T2
To identify the presence of cardiac magnetic resonance-derived cardiac inflammation using T2 mapping during and shortly after RT.
Baseline up to 6 months post-RT
Changes in myocardial metabolism
To identify changes in myocardial metabolism measured as standardized uptake value (SUV) max during and shortly after RT using myocardial PET.
Baseline up to 6 months post-RT
Secondary Outcomes (1)
Blood-based biomarkers
Baseline up 6 to months post-RT
Study Arms (1)
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.
Interventions
Undergo CMR
Undergo blood sample collection
Undergo cardiac PET/CT
Undergo cardiac PET/CT
Eligibility Criteria
Patients suitable to undergo thoracic RT for histologically confirmed non-small cell lung cancer (NSCLC) OR histologically confirmed clinical stage I-IVA (American Joint Committee on Cancer \[AJCC\] 8th edition \[ed\]) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) at Ohio State University Comprehensive Cancer Center
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric D Miller, MD, PhD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2021
First Posted
February 8, 2023
Study Start
April 2, 2021
Primary Completion (Estimated)
June 18, 2026
Study Completion (Estimated)
June 18, 2026
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share