Early Imaging Biomarkers in NSCLC

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Thoracic Cancer

Treatments: Other: Imaging Biomarkers; Other: Pulmonary; Other: Specimen Collection; Other: Imaging

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03121287

HUM00097162 (Other Identifier)

UMCC 2015.006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Lung or Esophageal Patients

Description:

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.

Treatment:

Other: Imaging

Other: Imaging Biomarkers

Other: Pulmonary

Other: Specimen Collection