Lung DiseasesEarly Phase 1NCT03532334
Comparison of 133Xe Scintigraphy With 19F MRI
A Early Phase 1 study testing Perfluorinated Gas/Oxygen Mixture in people with Lung Diseases, run by Hal C Charles at 1 site in United States.
Trial summary
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Perfluorinated Gas/Oxygen Mixture
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to Dec 2019
- 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 urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- 1. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
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: Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
Read the detailed description
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy
- Conditions
- Lung Diseases
- Being tested
- Perfluorinated Gas/Oxygen Mixture
- Keywords
- 19F MRI gas Ventilation, 133 XE ventilation Scintigraphy
- Medical subject headings
- Lung Diseases
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.
Efficacy of 19F MRI compared to 133 Xenon Scintigraphy
To evaluate the non-inferiority of 19F Perfluorinated gas MRI compared to 133 Xenon Scintigraphy ventilation imaging studies two readers will be selected as having experience reading Xe-133 ventilation scans. Readers will also receive training on interpretation of 19F ventilation images We note that the nature of the images both nuclear medicine and 19F MRI preclude blinding of the readers to the image modality. Images from each modality will be assessed independently and the images will be coded so that readers will not know which image set is from each subject.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start4 Apr 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: unable to accrue in subjects in a timely fashion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03532334
- Sponsor's protocol ID
- Pro00089045
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
- ClinicalTrials.gov ID
- NCT03532334
- Acronym / sponsor ID
- Pro00089045
- Conditions
- Lung Diseases
- Keywords
- 19F MRI gas Ventilation, 133 XE ventilation Scintigraphy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to accrue in subjects in a timely fashion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hal C CharlesUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 May 2018 (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 central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
Detailed description
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy
Study design
- Primary purpose
- Other
- 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 (5 listed)
- 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 urine pregnancy test. This will be confirmed before participation in this investigational protocol.
- Completion of 133Xe ventilation scintigraphy after referral for ventilation imaging for any reason in Pro00081987 A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy. The MRI will be accomplished in a timely fashion after the Scintigraphy study based on scheduling availability in the Center for Advanced Magnetic Resonance Development (CAMRD).
Key exclusion criteria (2 listed)
- 1. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
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
Efficacy of 19F MRI compared to 133 Xenon Scintigraphy
Time frame: 24 months
To evaluate the non-inferiority of 19F Perfluorinated gas MRI compared to 133 Xenon Scintigraphy ventilation imaging studies two readers will be selected as having experience reading Xe-133 ventilation scans. Readers will also receive training on interpretation of 19F ventilation images We note that the nature of the images both nuclear medicine and 19F MRI preclude blinding of the readers to the image modality. Images from each modality will be assessed independently and the images will be coded so that readers will not know which image set is from each subject.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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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 Lung Diseases, 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 24 Jul 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of 19F MRI compared to 133 Xenon Scintigraphy (time frame: 24 months). 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 24 Jul 2018.