Image and Model Based Analysis of Lung Disease

January 17, 2019 updated by: Eric A. Hoffman
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

341

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eric A. Hoffman

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 1997

Primary Completion (Actual)

June 5, 2015

Study Completion (Actual)

June 5, 2015

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199708651
  • 5R01HL064368 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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