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Completed

NCT Number: NCT03121287

Early Imaging Biomarkers in NSCLC

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging Biomarkers

Other

Whole lung volumetric CT scans

Pulmonary

Other

Pulmonary Function Tests & 6 minute hall walk

Imaging

Other

Cardiac MRI

Specimen Collection

Other

Blood draw

Primary outcomes

  1. Change from Baseline in Lung Function

    Time frame: 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 outcomes

  1. Change from Baseline in Myocardial Tissue

    Time frame: 1 Year post treatment

    To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, using cardiac MR in patients undergoing intrathoracic radiation therapy.

  2. Change from Baseline in Myocardial Tissue

    Time frame: 1 Year post treatment

    To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including microvascular dysfunction, using cardiac MR in patients undergoing intrathoracic radiation therapy.

  3. Change from Baseline in Myocardial Tissue

    Time frame: 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.

  4. Radiation Predictors from Baseline in Cardiopulmonary Changes

    Time frame: 1 Year post treatment

    To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes.

Other outcomes

  1. Radiation Induced Change from Baseline in Imaging

    Time frame: 6 month and 1 year post treatment

    To determine if early imaging-based changes are associated with radiation induced pulmonary and cardiac injury at 6- and 12-months

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2017
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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