NCT03121287

Early Imaging Biomarkers in NSCLC

Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Cancer

Interventions

Type	Name	Description
OTHER	Imaging Biomarkers	Whole lung volumetric CT scans
OTHER	Pulmonary	Pulmonary Function Tests \& 6 minute hall walk
OTHER	Imaging	Cardiac MRI
OTHER	Specimen Collection	Blood draw

Timeline

• Start date: 2015-09-23
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2017-04-20
• Last updated: 2019-08-26

Locations

1 site across 1 country: United States