Early Imaging Biomarkers in NSCLC

Thoracic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121287
• Other study ID #: UMCC 2015.006
• Secondary ID: HUM00097162
• Status: Completed
• Start date: September 23, 2015
• Est. completion date: January 2019

Study information

• Verified date: August 2019
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Cancer

Intervention

Other:
• Imaging Biomarkers
Whole lung volumetric CT scans
• Pulmonary
Pulmonary Function Tests & 6 minute hall walk
• Imaging
Cardiac MRI
• Specimen Collection
Blood draw

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiation Induced Change from Baseline in Imaging	To determine if early imaging-based changes are associated with radiation induced pulmonary and cardiac injury at 6- and 12-months	6 month and 1 year post treatment
Primary	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.	1 Year post treatment
Secondary	Change from Baseline in Myocardial Tissue	To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, using cardiac MR in patients undergoing intrathoracic radiation therapy.	1 Year post treatment
Secondary	Change from Baseline in Myocardial Tissue	To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including microvascular dysfunction, using cardiac MR in patients undergoing intrathoracic radiation therapy.	1 Year post treatment
Secondary	Change from Baseline in Myocardial Tissue	To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including diffuse fibrosis, using cardiac MR in patients undergoing intrathoracic radiation therapy.	1 Year post treatment
Secondary	Radiation Predictors from Baseline in Cardiopulmonary Changes	To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes.	1 Year post treatment