Clinical trial NCT03121287: Early Imaging Biomarkers in NSCLC
Official title: Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-04-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing conventionally-fractionated intrathoracic radiation therapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Lung Function
timeFrame: 1 Year post treatment
Secondary outcomes:
measure: Change from Baseline in Myocardial Tissue
timeFrame: 1 Year post treatment
measure: Change from Baseline in Myocardial Tissue
timeFrame: 1 Year post treatment
measure: Change from Baseline in Myocardial Tissue
timeFrame: 1 Year post treatment
measure: Radiation Predictors from Baseline in Cardiopulmonary Changes
timeFrame: 1 Year post treatment
Other outcomes:
measure: Radiation Induced Change from Baseline in Imaging
timeFrame: 6 month and 1 year post treatment
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Shruti Jolly, MD
role: PRINCIPAL_INVESTIGATOR
References: