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Early Imaging Biomarkers in NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03121287
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thoracic Cancer Other: Imaging Biomarkers Other: Pulmonary Other: Imaging Other: Specimen Collection

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.

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
Actual Study Start Date : September 23, 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lung or Esophageal Patients
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.
Other: Imaging Biomarkers
Whole lung volumetric CT scans

Other: Pulmonary
Pulmonary Function Tests & 6 minute hall walk

Other: Imaging
Cardiac MRI

Other: Specimen Collection
Blood draw




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing conventionally-fractionated intrathoracic radiation therapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121287


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Department of Health and Human Services
Investigators
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Principal Investigator: Shruti Jolly, MD University of Michigan
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03121287    
Other Study ID Numbers: UMCC 2015.006
HUM00097162 ( Other Identifier: U-M IRB )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No