Thoracic Cancer Clinical Trial
Official title:
Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
Verified date | August 2019 |
Source | University of Michigan Rogel Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Rogel Cancer Center | Department of Health and Human Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Change from Baseline in Myocardial Tissue | 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 | |
Secondary | 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 | |
Secondary | Radiation Predictors from Baseline in Cardiopulmonary Changes | To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes. | 1 Year post treatment |
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