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Cystic FibrosisEarly Phase 1NCT03482960

Comparison of 129Xe MRI With 19F MRI in CF Lung Disease

A Early Phase 1 study testing Hyperpolarized Xenon gas and PFP in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cystic Fibrosis
What is being tested?
Hyperpolarized Xenon gas and PFP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
29 May 2018to 10 Apr 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects with CF must meet all of the following inclusion criteria to be eligible for enrollment:
  • Subjects must be at least 18 years of age;
  • Non-smokers (<10 pack year history and no active smoking in the past year);
  • Diagnosis of cystic fibrosis as via standard sweat chloride/phenotypic features/genotyping
  • Stable lung disease as evidenced by no change in respiratory medications or change in forced expiratory volume in 1 second (FEV1) of >15% from baseline over the preceding 4 weeks prior to enrollment
  • Baseline FEV1 >70% of predicted.
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  • No use of supplemental oxygen
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
  • Subjects must be willing and able to comply with scheduled visits and other trial procedures.
  • Subjects without CF must meet all of the following inclusion criteria to be eligible for enrollment:
  • Subjects must be at least 18 years of age;
  • Non-smokers (<10 pack year history and no active smoking in the past year);
  • Baseline FEV1 >70% of predicted.
  • No use of supplemental oxygen or clinically significant lung disease
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
  • Subjects must be willing and able to comply with scheduled visits and other trial procedures.

Who cannot join

  • Active or past smokers with less than 1 years since quitting or >10 pack-year smoking history
  • Co-existent asthma (as evidenced by either clinical diagnosis, chronic oral steroid use, or marked broncho-reactivity on pulmonary function testing)
  • Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including
  • Occupation (past or present) of machinist, welder, grinder;
  • Injury to the eye involving a metallic object
  • Injury to the body by a metallic object (bullet, BB, shrapnel)
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  • Presence of a cardiac pacemaker or defibrillator
  • Presence of aneurysm clips
  • Presence of carotid artery vascular clamp
  • Presence of neurostimulator
  • Presence of insulin or infusion pump
  • Presence of implanted drug infusion device that is not known to be MRI compatible (i.e., was placed outside of UNCH or is older than 10 years)
  • Bone growth or fusion simulator
  • Presence of cochlear, otologic or ear implant
  • Any type of prosthesis (eye, penile, etc.)
  • Artificial limb or joint
  • Non-removable electrodes (on body, head or brain)
  • Intravascular stents, filters or coils
  • Shunt (spinal or intraventricular)
  • Swan-ganz catheter
  • Any implant held in place by a magnet
  • Transdermal delivery system (e.g. Nitro)
  • Intrauterine Device (IUD) or diaphragm
  • Tattooed makeup (eyeliner, lips, etc.) or tattoos covering >25% of body surface area
  • Body piercings (MUST BE REMOVED BEFORE MRI)
  • Any metal fragments
  • Internal pacing wires
  • Metal or wire mesh implants
  • Hearing aid (REMOVE BEFORE MRI)
  • Dentures (REMOVE BEFORE MRI)
  • Claustrophobia
  • Unable to tolerate inhalation of gas mixture
  • Any changes in medications that may affect CF lung disease in the past 14 days, including any experimental therapies
  • 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.
  • Pregnancy; women of childbearing potential must have a confirmed negative urine pregnancy test on the day of the MRI scan, prior to the MRI scan.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI.

Read the detailed description

The goal of this study is to compare the capabilities of two novel imaging techniques: conventional 'thermally' polarized perfluorinated gases (perfluoropropane, or PFP) mixed with oxygen, and hyperpolarized xenon (129Xe) mixed with N2 to detect changes in lung ventilation using magnetic resonance imaging (MRI). Although considerable work has been done internationally with hyperpolarized xenon MRI, the low availability and high cost of this technique is limiting. Perfluorinated gas MRI is an alternative that may in fact be a suitable, simpler alternative. PFP is commercially availability in large quantities, which allows multiple breath studies and thus provides the ability to analyze gas wash-in and wash-out kinetics. These endpoints may improve the investigators ability to detect ventilation abnormalities beyond the traditional "ventilation defect percentage" parameter obtained with 129Xe MRI. The commercial availability of PFP and lack of need for onsite hyperpolarization may also facilitate the transfer of this technology to other centers for the conduct of multicenter studies. The investigators hypothesize that 19F MRI will not be inferior to hyperpolarized xenon MRI in detection of ventilation defect percentages (VDP).

Conditions
Cystic Fibrosis
Being tested
Hyperpolarized Xenon gas, PFP
Keywords
imaging, hyperpolarized, perfluorinated, MRI, lung
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperpolarized Xenon gasDrug

    Also called 129Xe

    Hyperpolarized Xenon gas

    • Hyperpolarized mixture (750ml HP 129Xe and 250ml nitrogen)
    • Administration: By mouthpiece attached to a single use Tedlar bag.
    • Dosage: 750 mL of the 129Xe mixture up to, but not exceeding, four doses of the 129Xe.
    • Frequency: 10-minute interval between doses.

  • PFPDrug

    Also called Perfluoropropane gas (C3F8); 19F

    • Inhaled PFP, a gaseous contrast agent (79% PFP; 21% O2, pre-mixed, medical grade gas)
    • Administration: Full-face disposable ventilation mask and a standard Douglas Bag system.
    • Dosage: Two controlled breaths of the contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition.
    • Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred.
Study groups in NCT03482960
Study groupRoleWhat they receive
129Xe MRIExperimentalParticipants will self-administer hyperpolarized xenon gas via inhalation prior to the investigators acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant will return to the MRI scanner, where the second phase of the study will occur. PFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath.
Receives: Drug: Hyperpolarized Xenon gas; Drug: PFP
19F MRI with PFPExperimentalPFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath. After the MRI is complete, participant performs spirometry maneuvers in a room outside the magnet. Once a minimum of 15 minutes has elapsed since leaving the MRI scanner, the participant returns to the MRI scanner, where he/she will self-administer hyperpolarized xenon gas prior to acquiring MRI images. MRI imaging will be taken during approximately 15-second breath-holds.
Receives: Drug: Hyperpolarized Xenon gas; Drug: PFP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP

    Primary comparison will be the VDP with Xenon (single breath) and after first PFP inhalation cycle (3 breaths of PFP)

    Measured: 1 hour

Secondary outcomes (3)

  1. Signal-to-noise (SNR) of each modality

    Assessment of the quality of signal achieved with each modality

    Measured: 20 minutes

  2. Rate constant describing wash-in and wash-out of PFP

    change in ventilated areas of the lung over time when administered PFP

    Measured: 15 minutes

  3. Correlation between VDP identified by each modality and spirometry and Lung Clearance Index (LCI)

    Comparison of VDP to two standard metrics of lung function, spirometry and LCI

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start29 May 2018
  3. Primary completion9 Apr 2019
  4. Study completion10 Apr 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482960
Sponsor's protocol ID
17-2569
Other IDs
XePFP2017
Status last verified
Sep 2020
First submitted
23 Mar 2018
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McCallister A, Chung SH, Antonacci M, Z Powell M, Ceppe AS, Donaldson SH, Lee YZ, Branca RT, Goralski JL. Comparison of single breath hyperpolarized 129 Xe MRI with dynamic 19 F MRI in cystic fibrosis lung disease. Magn Reson Med. 2021 Feb;85(2):1028-1038. doi: 10.1002/mrm.28457. Epub 2020 Aug 8.

    PubMed 32770779

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hyperpolarized Xenon gas and PFP in people with Cystic Fibrosis, run by University of North Carolina, Chapel Hill 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 16 inclusion and 35 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 25 Jan 2021. 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?

Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482960, which also lists 1 linked publication.

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 25 Jan 2021.

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