Early Imaging Biomarkers in NSCLC

University of Michigan Rogel Cancer Center23 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thoracic Cancer

Interventions

Imaging BiomarkersOTHER

Whole lung volumetric CT scans

PulmonaryOTHER

Pulmonary Function Tests \& 6 minute hall walk

ImagingOTHER

Cardiac MRI

Specimen Collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.