Image and Model Based Analysis of Lung Disease

NCT03764163 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 1997086515R01HL064368
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Normal lung aging assessed by CT imaging

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

  up to 10 years

Study Arms (1)

Study Participants

EXPERIMENTAL

Pulmonary Function Test, Questionnaires, CT scans, perfusion scan, ventilation scan, Xenon gas ventilation CT scan with hyperpolarized 3-Helium MRI Scan.

Diagnostic Test: Pulmonary Function Test; Diagnostic Test: CT Scans; Behavioral: Questionnaires; Diagnostic Test: MRI; Biological: Xenon gas

Interventions

Pulmonary Function Test DIAGNOSTIC_TEST

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

Study Participants

CT Scans DIAGNOSTIC_TEST

volume scans, perfusion scan, ventilation scan

Study Participants

Questionnaires BEHAVIORAL

Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire

Study Participants

MRI DIAGNOSTIC_TEST

proton scans, hyperpolarized 3-Helium scan

Study Participants

Xenon gas BIOLOGICAL

ventilation CT scans

Study Participants

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eric A. Hoffman: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Function Tests; Tomography, X-Ray Computed; Surveys and Questionnaires; Lasers, Gas

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Eric A Hoffman, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: December 4, 2018
• Study Start: September 30, 1997
• Primary Completion: June 5, 2015
• Study Completion: June 5, 2015
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available starting 6 months after publication of the primary results of each aim
• Access Criteria: Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, PhD. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. This costs will not exceed $250. This service will be available for a minimum of 2 years of study close.

Locations

US (1)