Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006)

NCT03237364 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: Pro00076112
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in subjects with suspected lung disease, post deployment in Iraq and Afghanistan. This is an open label proof of concept study expanding on work here at Duke.

Conditions

Constrictive Bronchiolitis; Iraq-Afganistan War Lung Injury Syndrome

Keywords

deployed in Iraq and/or Afghanistan

Outcome Measures

Primary Outcomes (1)

• Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures

  Fraction of lung with slow filling compartments compared to historic norms.

  one hour

Interventions

Perfluorinated Gas/Oxygen Mixture DIAGNOSTIC_TEST

19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, \< 1 hour

Also known as: Perfluorinated Propane Imaging

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of either gender, age \> 18.
• Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
• Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
• Subjects must have been deployed in Iraq and/or Afghanistan
• Subjects must have a strong clinical suspicion of a diagnosis of constrictive bronchiolitis based on clinical presentation and spirometry results

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications (e.g. metal in the eye, claustrophobia);
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
• Unable to receive gas mixture by breathing because of contraindications;
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
• Female; women at risk of pregnancy are required to have a confirmed negative urine pregnancy test at Screening if of childbearing potential prior to the MRI scan

Sponsors & Collaborators

• Hal C Charles: lead

Study Sites (1)

Duke Image Analysis Laboratory

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Cecil Charles, PhD

  Duke University Medical Center, Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: August 19, 2017
• Primary Completion: March 1, 2019
• Study Completion: February 28, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)