Image and Model Based Analysis of Lung Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Image and Model Based Analysis of Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764163
• Other study ID #: 199708651
• Secondary ID: 5R01HL064368
• Status: Completed
• Phase: Early Phase 1
• Start date: September 30, 1997
• Est. completion date: June 5, 2015

Study information

• Verified date: January 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: June 5, 2015
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Pulmonary Function Test
Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes
• 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

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Eric A. Hoffman	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal lung aging assessed by CT imaging	Normal aging process of the lungs compared to common smoking related lung diseases.	up to 10 years