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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00097162 | Other Identifier | U-M IRB |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT scans can detect early changes to the associated with radiation therapy in patients receiving radiation treatment for thoracic cancer.
This study seeks to investigate the utility of novel imaging biomarkers, namely whole lung volumetric CT scans and cardiac MRI, to non-invasively identify early pathologic changes in pulmonary and cardiac function resulting from thoracic radiation. The ability to identify these changes during the course of treatment offers a powerful tool to optimize radiation dose distributions within uninvolved normal tissue by adapting treatment to the individual patient response. In addition it may lead to other therapeutic interventions designed to reduce long term cardiopulmonary toxicity.
The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung or Esophageal Patients | Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test & 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging Biomarkers | Other | Whole lung volumetric CT scans |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Lung Function | To characterize longitudinal changes in lung function using a voxel-wise image analysis technique of whole-lung CT scans in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Myocardial Tissue | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, using cardiac MR in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment |
| Change from Baseline in Myocardial Tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Induced Change from Baseline in Imaging | To determine if early imaging-based changes are associated with radiation induced pulmonary and cardiac injury at 6- and 12-months | 6 month and 1 year post treatment |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing conventionally-fractionated intrathoracic radiation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Shruti Jolly, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| Pulmonary |
| Other |
Pulmonary Function Tests & 6 minute hall walk |
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| Imaging | Other | Cardiac MRI |
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| Specimen Collection | Other | Blood draw |
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To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including microvascular dysfunction, using cardiac MR in patients undergoing intrathoracic radiation therapy. |
| 1 Year post treatment |
| Change from Baseline in Myocardial Tissue | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including diffuse fibrosis, using cardiac MR in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment |
| Radiation Predictors from Baseline in Cardiopulmonary Changes | To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes. | 1 Year post treatment |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |