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Clinical Trials/NCT03764163
NCT03764163
Completed
Early Phase 1

Image and Model Based Analysis of Lung Disease

Eric A. Hoffman1 site in 1 country341 target enrollmentSeptember 30, 1997

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
Eric A. Hoffman
Enrollment
341
Locations
1
Primary Endpoint
Normal lung aging assessed by CT imaging
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 1997
End Date
June 5, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Eric A. Hoffman
Responsible Party
Sponsor Investigator
Principal Investigator

Eric A. Hoffman

Professor

University of Iowa

Eligibility Criteria

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

Outcomes

Primary Outcomes

Normal lung aging assessed by CT imaging

Time Frame: up to 10 years

Normal aging process of the lungs compared to common smoking related lung diseases.

Study Sites (1)

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