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OpenTrials
Completed

NCT Number: NCT03764163

Image and Model Based Analysis of Lung Disease

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.

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Key information

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pulmonary Function Test

Diagnostic Test

Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes

CT scans

Diagnostic Test

volume scans, perfusion scan, ventilation scan

Questionnaires

Behavioral

Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

MRI

Diagnostic Test

proton scans, hyperpolarized 3-Helium scan

Xenon gas

Biological

ventilation CT scans

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eric A. Hoffman

Other

Collaborators

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

Registry information

Important dates

Study start
1997
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2018
Registry last updated
Jan 22, 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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