Image and Model Based Analysis of Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2015-06-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study Participants

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

Group Type EXPERIMENTAL

Pulmonary Function Test

Intervention Type DIAGNOSTIC_TEST

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

CT Scans

Intervention Type DIAGNOSTIC_TEST

volume scans, perfusion scan, ventilation scan

Questionnaires

Intervention Type BEHAVIORAL

Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

MRI

Intervention Type DIAGNOSTIC_TEST

proton scans, hyperpolarized 3-Helium scan

Xenon gas

Intervention Type BIOLOGICAL

ventilation CT scans

Interventions

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Pulmonary Function Test

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

Intervention Type DIAGNOSTIC_TEST

CT Scans

volume scans, perfusion scan, ventilation scan

Intervention Type DIAGNOSTIC_TEST

Questionnaires

Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

Intervention Type BEHAVIORAL

MRI

proton scans, hyperpolarized 3-Helium scan

Intervention Type DIAGNOSTIC_TEST

Xenon gas

ventilation CT scans

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes