NCT03764163

Image and Model Based Analysis of Lung Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Eric A. Hoffman · Academic / Other
• Sex: All
• Age: 20 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
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

Timeline

• Start date: 1997-09-30
• Primary completion: 2015-06-05
• Completion: 2015-06-05
• First posted: 2018-12-04
• Last updated: 2019-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study