Thoracic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERImaging Biomarkers
Whole lung volumetric CT scans
OTHERPulmonary
Pulmonary Function Tests & 6 minute hall walk
OTHERImaging
Cardiac MRI
OTHERSpecimen Collection
Blood draw
Sponsors
Department of Health and Human Services
University of Michigan Rogel Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving once daily fractionated intrathoracic radiation therapy for: * Stage IIA-IIIB non-small cell lung cancer * Limited stage small cell lung cancer * Stage I-III esophageal cancer (neoadjuvant or definitive) * Patients must be 18 years of age or older * Must not be claustrophobic * Must have adequate kidney function
Exclusion criteria
* Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation * Patients with esophageal cancer receiving trastuzamab * Pregnancy or lactation * Claustrophobia * Inability to lie flat for 60-90 minutes * Renal dysfunction with eGFR \<60 mL/min/1.73 m2 * Allergy to gadolinium containing contrast media * Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Lung Function | 1 Year post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Myocardial Tissue | 1 Year post treatment | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, using cardiac MR in patients undergoing intrathoracic radiation therapy. |
| Radiation Predictors from Baseline in Cardiopulmonary Changes | 1 Year post treatment | To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiation Induced Change from Baseline in Imaging | 6 month and 1 year post treatment | To determine if early imaging-based changes are associated with radiation induced pulmonary and cardiac injury at 6- and 12-months |
Countries
United States
Outcome results
None listed