Constrictive BronchiolitisEarly Phase 1NCT03237364
Iraq- Afghanistan War Lung Injury Using 19F MRI (DIAL1001006)
A Early Phase 1 study testing Perfluorinated Gas/Oxygen Mixture in people with Constrictive Bronchiolitis and Iraq-Afganistan War Lung Injury Syndrome, run by Hal C Charles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Constrictive Bronchiolitis, Iraq-Afganistan War Lung Injury Syndrome
- What is being tested?
- Perfluorinated Gas/Oxygen Mixture
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2017to 28 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Image Analysis Laboratory
Durham, North Carolina, 27705
About this study
Official title: Evaluation of Regional Lung Function in U.S. Soldiers With Suspected Iraq-Afghanistan War Lung Injury Using 19F MRI
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.
Read the 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 soldiers but evaluation of particulates from the Middle East in a number of animal models. While there have been some 'prospective' studies based on use of a standard evaluation protocol post deployment, the primary imaging modalities have been chest radiograph (most read as normal) and chest high resolution computed tomography (HRCT), neither of which have significant functional information. Standard pulmonary function testing (e.g. spirometry, lung volumes, diffusing capacity, bronchoalveolar lavage, as well as oscillatory resistance) were used in the STAMPEDE study, but only provide global functional information. The case study by King et al. included lung biopsy in a sub-cohort (n = 49) of soldiers with varying degrees of inhalation exposure during deployment. All biopsy samples were abnormal and some were consistent with constrictive bronchiolitis. Constrictive bronchiolitis is a non-reversible bronchiolar airway disease that is characterized by fibrosis of the bronchioles and can be challenging to diagnose without biopsy (it is also known by the term 'bronchiolitis obliterans'). The chest radiographs were normal in these subjects although about 25% of chest CT showed 'air trapping' or 'centrilobular nodules'. Pulmonary function testing in 39 soldiers with HRCT showed normal to near normal results in 32 of the subjects, with seven showing low diffusion capacity, obstruction and/or restriction. Clearly, neither global measures of lung function nor high resolution anatomic imaging are sensitive enough to avoid a biopsy to confirm diagnosis of constrictive bronchiolitis. We hypothesize that measures of regional lung function should provide additional information to aid in the diagnosis of WLI and may assist in the management of more difficult or advanced cases of WLI.
This is an open label study in up to 10 subjects being evaluated for post war lung injury. Each subject will receive up to 25 liters of inert perfluoropropane/oxygen gas mixtures as a contrast agent to visualize the airway and alveolar spaces in their lungs using 19F magnetic resonance imaging of inert gas/oxygen mixtures.
- Being tested
- Perfluorinated Gas/Oxygen Mixture
- Keywords
- deployed in Iraq and/or Afghanistan
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfluorinated Gas/Oxygen MixtureDiagnostic test
Also called Perfluorinated Propane Imaging
19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures
Fraction of lung with slow filling compartments compared to historic norms.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start19 Aug 2017
- Primary completion1 Mar 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constrictive BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hal C Charles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hal C Charles, Duke University
- Investigators
- Cecil Charles, PhD, Principal investigator, Duke University Medical Center, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237364
- Sponsor's protocol ID
- Pro00076112
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Lung Function in U.S. Soldiers With Suspected Iraq-Afghanistan War Lung Injury Using 19F MRI
- ClinicalTrials.gov ID
- NCT03237364
- Acronym / sponsor ID
- Pro00076112
- Keywords
- deployed in Iraq and/or Afghanistan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hal C CharlesUniversity, hospital or other
- Study start
- 19 Aug 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 soldiers but evaluation of particulates from the Middle East in a number of animal models. While there have been some 'prospective' studies based on use of a standard evaluation protocol post deployment, the primary imaging modalities have been chest radiograph (most read as normal) and chest high resolution computed tomography (HRCT), neither of which have significant functional information. Standard pulmonary function testing (e.g. spirometry, lung volumes, diffusing capacity, bronchoalveolar lavage, as well as oscillatory resistance) were used in the STAMPEDE study, but only provide global functional information. The case study by King et al. included lung biopsy in a sub-cohort (n = 49) of soldiers with varying degrees of inhalation exposure during deployment. All biopsy samples were abnormal and some were consistent with constrictive bronchiolitis. Constrictive bronchiolitis is a non-reversible bronchiolar airway disease that is characterized by fibrosis of the bronchioles and can be challenging to diagnose without biopsy (it is also known by the term 'bronchiolitis obliterans'). The chest radiographs were normal in these subjects although about 25% of chest CT showed 'air trapping' or 'centrilobular nodules'. Pulmonary function testing in 39 soldiers with HRCT showed normal to near normal results in 32 of the subjects, with seven showing low diffusion capacity, obstruction and/or restriction. Clearly, neither global measures of lung function nor high resolution anatomic imaging are sensitive enough to avoid a biopsy to confirm diagnosis of constrictive bronchiolitis. We hypothesize that measures of regional lung function should provide additional information to aid in the diagnosis of WLI and may assist in the management of more difficult or advanced cases of WLI.
This is an open label study in up to 10 subjects being evaluated for post war lung injury. Each subject will receive up to 25 liters of inert perfluoropropane/oxygen gas mixtures as a contrast agent to visualize the airway and alveolar spaces in their lungs using 19F magnetic resonance imaging of inert gas/oxygen mixtures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
Key exclusion criteria (6 listed)
- Subjects presenting with any of the following will not be included in the 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perfluorinated Gas/Oxygen MixtureAlso: Perfluorinated Propane Imaging19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour | Diagnostic test | – |
Primary outcome
Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures
Time frame: one hour
Fraction of lung with slow filling compartments compared to historic norms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecil Charles, PhD principal investigator
Duke University Medical Center, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Perfluorinated Gas/Oxygen Mixture in people with Constrictive Bronchiolitis and Iraq-Afganistan War Lung Injury Syndrome, run by Hal C Charles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Ventilatory Heterogeneity defined by parametric imaging with 19F perfluorinated gas/oxygen mixtures (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.