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Image and Model Based Analysis of Lung Disease

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ClinicalTrials.gov Identifier: NCT03764163
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Eric A. Hoffman, University of Iowa

Brief Summary:
The purpose of this research study is to develop CT scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Diagnostic Test: Pulmonary Function Test Diagnostic Test: CT Scans Behavioral: Questionnaires Diagnostic Test: MRI Biological: Xenon gas Early Phase 1

Detailed Description:
Specifically, the investigators are interested in understanding the difference between the normal aging process and the events that lead to emphysema. Additionally, the investigators are interested in understanding the earliest signs (lung inflammation) of the disease process leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of which are described as "inflammatory lung diseases." The investigators will be using the data from this study to help define the normal values for the measured properties as well as deviation from normal values in smokers without defined lung disease and patients with inflammatory lung disease. The investigators believe that the analysis and scanning techniques being developed as part of this research will provide new and previously unavailable information on normal and diseased lungs so that ultimately the investigators can detect specific changes in the lungs due to a disease and measure any improvements in the anatomy and/or function of the pulmonary system after a patient has undergone treatment. This study involves research using X-Ray computed tomography (CT) scanner, which is similar to previous CT scanners but operates much faster and provides finer image detail.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Image and Model Based Analysis of Lung Disease
Actual Study Start Date : September 30, 1997
Actual Primary Completion Date : June 5, 2015
Actual Study Completion Date : June 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Experimental: Study Participants
Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Diagnostic Test: Pulmonary Function Test
Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes

Diagnostic Test: CT Scans
volume scans, perfusion scan, ventilation scan

Behavioral: Questionnaires
Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

Diagnostic Test: MRI
proton scans, hyperpolarized 3-Helium scan

Biological: Xenon gas
ventilation CT scans




Primary Outcome Measures :
  1. Normal lung aging assessed by CT imaging [ Time Frame: up to 10 years ]
    Normal aging process of the lungs compared to common smoking related lung diseases.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20 cigarettes in their lifetime
  • Smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20 cigarettes) per day, normal smokers and mild to moderate Chronic Obstructive Pulmonary Disease (COPD)

Exclusion Criteria:

  • Allergies - no allergies to shellfish, eggs, iodine
  • Medications - no medications (except for birth control) for in the 'normal' category
  • No asthma - as self reported
  • BMI (Body Mass Index) - must not exceed 32 or 100kg of weight
  • No other radiology studies in the last 12 months
  • No metal in lung field - no metal from larynx to stomach
  • No known heart disease
  • No known kidney disease or diabetes
  • Must not be pregnant - subjects of childbearing potential with be given a urine pregnancy test

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): NCT03764163


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Eric A. Hoffman
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Eric A Hoffman, PhD University of Iowa

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Responsible Party: Eric A. Hoffman, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03764163     History of Changes
Other Study ID Numbers: 199708651
5R01HL064368 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be made available starting 6 months after publication of the primary results of each aim
Access Criteria: Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, PhD. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. This costs will not exceed $250. This service will be available for a minimum of 2 years of study close.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs