Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Lung Function
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change from Baseline in Lung Function
Time Frame: 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 Outcomes
- Change from Baseline in Myocardial Tissue(1 Year post treatment)
- Radiation Predictors from Baseline in Cardiopulmonary Changes(1 Year post treatment)