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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08714 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood-based biomarkers | Biomarkers including serum troponin, N-terminal Pro Brain-type Natriuretic Peptide (NT-proBNP), C-reactive protein, carboxy-terminal propeptide of procollagen type I (PICP), and amino-terminal propeptide of procollagen type I (PINP) will be measured. | Baseline up 6 to months post-RT |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Eric D Miller, MD, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Blood
| Computed Tomography | Procedure | Undergo cardiac PET/CT |
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| Magnetic Resonance Imaging of the Heart | Procedure | Undergo CMR |
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| Positron Emission Tomography | Procedure | Undergo cardiac PET/CT |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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