Status:
COMPLETED
Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006)
Lead Sponsor:
Hal C Charles
Conditions:
Constrictive Bronchiolitis
Iraq-Afganistan War Lung Injury Syndrome
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
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 su...
Detailed Description
There has been mounting evidence of respiratory problems related to military service in the Middle East especially in the past two decades. An overview by Flavo et al. summarizes studies not only of s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03237364
Start Date
August 19 2017
End Date
February 28 2020
Last Update
March 10 2020
Active Locations (1)
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1
Duke Image Analysis Laboratory
Durham, North Carolina, United States, 27705