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

Completed · Early Phase 1

Conditions studied: Constrictive Bronchiolitis, Iraq-Afganistan War Lung Injury Syndrome

In brief

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.

Key facts

Study ID

NCT03237364

Run by

Hal C Charles

People needed

7

Starts

2017-08-19

Expected to finish

2020-02-28

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
• 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

Where it is running

• Duke Image Analysis Laboratory — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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