Early Imaging Biomarkers in NSCLC

Completed

• Conditions: Thoracic Cancer
• Interventions: Other: Imaging Biomarkers; Other: Pulmonary; Other: Imaging; Other: Specimen Collection

• Registration Number: NCT03121287
• Lead Sponsor: University of Michigan Rogel Cancer Center

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 Timeline

• Study Start: 2015-09-23
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-20
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung or Esophageal Patients	Imaging Biomarkers	Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.
Lung or Esophageal Patients	Pulmonary	Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.
Lung or Esophageal Patients	Specimen Collection	Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.
Lung or Esophageal Patients	Imaging	Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from Baseline in Myocardial Tissue	1 Year post treatment	To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including diffuse fibrosis, 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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States