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Image and Model Based Analysis of Lung Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Function Test
CT Scans
Questionnaires
MRI
Xenon gas
Sponsored by
Eric A. Hoffman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

20 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Participants

Arm Description

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

Outcomes

Primary Outcome Measures

Normal lung aging assessed by CT imaging
Normal aging process of the lungs compared to common smoking related lung diseases.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2018
Last Updated
January 17, 2019
Sponsor
Eric A. Hoffman
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03764163
Brief Title
Image and Model Based Analysis of Lung Disease
Official Title
Image and Model Based Analysis of Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 1997 (Actual)
Primary Completion Date
June 5, 2015 (Actual)
Study Completion Date
June 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric A. Hoffman
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
341 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Participants
Arm Type
Experimental
Arm Description
Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulmonary Function Test
Intervention Description
Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Scans
Intervention Description
volume scans, perfusion scan, ventilation scan
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
proton scans, hyperpolarized 3-Helium scan
Intervention Type
Biological
Intervention Name(s)
Xenon gas
Intervention Description
ventilation CT scans
Primary Outcome Measure Information:
Title
Normal lung aging assessed by CT imaging
Description
Normal aging process of the lungs compared to common smoking related lung diseases.
Time Frame
up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A Hoffman, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Data will be made available starting 6 months after publication of the primary results of each aim
IPD Sharing 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.

Learn more about this trial

Image and Model Based Analysis of Lung Disease

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