Image and Model Based Analysis of Lung Disease

Early Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Diagnostic Test: Pulmonary Function Test; Diagnostic Test: CT Scans; Behavioral: Questionnaires; Diagnostic Test: MRI; Biological: Xenon gas

• Registration Number: NCT03764163
• Lead Sponsor: Eric A. Hoffman

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.

Study Timeline

• Study Start: 1997-09-30
• Primary Completion: 2015-06-05
• Study Completion: 2015-06-05
• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	Questionnaires	Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Study Participants	CT Scans	Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Study Participants	Xenon gas	Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Study Participants	Pulmonary Function Test	Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.
Study Participants	MRI	Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

Primary Outcome Measures

Name	Time	Method
Normal lung aging assessed by CT imaging	up to 10 years	Normal aging process of the lungs compared to common smoking related lung diseases.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States