Post Single or Double Lung TransplantPhase 1DIAL1001005NCT02019251
Lung Transplant Subjects Using 19F MRI
A Phase 1 study testing perfluorinated gas/oxygen mixture and MRI in people with Post Single or Double Lung Transplant, 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 inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Single or Double Lung Transplant
- What is being tested?
- perfluorinated gas/oxygen mixture and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2014
- Phase
- 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 years and older
- 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:
- Subjects must be ≥ 18 years of age;
- Post single or double lung transplant;
- Subjects who are willing and able to comply with scheduled visits and other trial procedures
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);
- Unable to receive gas mixture by breathing because of contraindications;
- Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
- 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 blood 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 University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Evaluation of Regional Lung Function in Lung Transplant Recipients Using 19F Magnetic Resonance Imaging of Inert Perfluorinated Gases Mixed With Oxygen
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. This is an open label study expanding on current work here at Duke. Images will be obtained using 19F MRI during wash-in and washout for evaluation of ventilation efficiency.
Read the detailed description
This is an open label study in up to 10 lung transplant recipients post lung transplantation whose post-transplant status is being monitored according to local standard of care. Each subject will receive up to 20 liters of PFP/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.
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 transplanted lungs. This is an open label proof of concept study expanding on work here at Duke.
The central hypothesis and current observation is that PFx gases, when used as contrast agents, provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. We will test the central hypothesis and accomplish the overall objective by addressing the following specific aims:
Primary Study Aims/Secondary Aims Aim 1: Determine qualitative and quantitative measures of lung ventilation performance in terms of ventilation efficiency during wash-in evaluation of the 19F images of lung airspaces.
Aim 2: Determine qualitative and quantitative measures of lung ventilation performance in terms of direct measures of gas trapping measured during washout of the perfluorinated gas mixture.
The outcomes of the work proposed in the aims is expected to demonstrate a non-invasive novel quantitative approach for evaluation of regional lung function in subjects with lung transplants that would allow repeated evaluation of lung function post-transplant to monitor for chronic allograft rejection.
- Conditions
- Post Single or Double Lung Transplant
- Being tested
- perfluorinated gas/oxygen mixture, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfluorinated gas/oxygen mixtureDrug
Subjects are imaged with MRI one time with the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Post single or double lung transplant | Experimental | The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using Disposable Face mask and a standard Douglas Bag system. Receives: Drug: perfluorinated gas/oxygen mixture; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation
Measured: 1 day (Single exposure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Single or Double Lung TransplantStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019251
- Sponsor's protocol ID
- Pro00047929
- Other IDs
- DIAL1001005
- Acronym
- DIAL1001005
- Status last verified
- Nov 2014
- First submitted
- 18 Dec 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Lung Function in Lung Transplant Recipients Using 19F Magnetic Resonance Imaging of Inert Perfluorinated Gases Mixed With Oxygen
- ClinicalTrials.gov ID
- NCT02019251
- Acronym / sponsor ID
- DIAL1001005 / Pro00047929
- Conditions
- Post Single or Double Lung Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hal C CharlesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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 inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. This is an open label study expanding on current work here at Duke. Images will be obtained using 19F MRI during wash-in and washout for evaluation of ventilation efficiency.
Detailed description
This is an open label study in up to 10 lung transplant recipients post lung transplantation whose post-transplant status is being monitored according to local standard of care. Each subject will receive up to 20 liters of PFP/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.
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 transplanted lungs. This is an open label proof of concept study expanding on work here at Duke.
The central hypothesis and current observation is that PFx gases, when used as contrast agents, provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. We will test the central hypothesis and accomplish the overall objective by addressing the following specific aims:
Primary Study Aims/Secondary Aims Aim 1: Determine qualitative and quantitative measures of lung ventilation performance in terms of ventilation efficiency during wash-in evaluation of the 19F images of lung airspaces.
Aim 2: Determine qualitative and quantitative measures of lung ventilation performance in terms of direct measures of gas trapping measured during washout of the perfluorinated gas mixture.
The outcomes of the work proposed in the aims is expected to demonstrate a non-invasive novel quantitative approach for evaluation of regional lung function in subjects with lung transplants that would allow repeated evaluation of lung function post-transplant to monitor for chronic allograft rejection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post single or double lung transplant | Experimental | Drug: perfluorinated gas/oxygen mixture, Device: MRIThe subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using Disposable Face mask and a standard Douglas Bag system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Subjects must be ≥ 18 years of age;
- Post single or double lung transplant;
- Subjects who are willing and able to comply with scheduled visits and other trial procedures
Key exclusion criteria (6 listed)
- 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);
- Unable to receive gas mixture by breathing because of contraindications;
- Participation in a clinical trial with a study drug that may impact lung function in the past 14 days; or
- 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.
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 mixtureSubjects are imaged with MRI one time with the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function. | Drug | Post single or double lung transplant |
| MRI | Device | Post single or double lung transplant |
Primary outcome
obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation
Time frame: 1 day (Single exposure)
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 18 Nov 2014.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing perfluorinated gas/oxygen mixture and MRI in people with Post Single or Double Lung Transplant, 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 4 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 18 Nov 2014. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation (time frame: 1 day (Single exposure)). 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 18 Nov 2014.