Skip to content

Image and Model Based Analysis of Lung Disease

Image and Model Based Analysis of Lung Disease

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03764163
Enrollment
341
Registered
2018-12-04
Start date
1997-09-30
Completion date
2015-06-05
Last updated
2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DIAGNOSTIC_TESTPulmonary Function Test

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

DIAGNOSTIC_TESTCT Scans

volume scans, perfusion scan, ventilation scan

BEHAVIORALQuestionnaires

Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

DIAGNOSTIC_TESTMRI

proton scans, hyperpolarized 3-Helium scan

BIOLOGICALXenon gas

ventilation CT scans

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Normal lung aging assessed by CT imagingup to 10 yearsNormal aging process of the lungs compared to common smoking related lung diseases.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026