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

January 21, 2021 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects with CF must meet all of the following inclusion criteria to be eligible for enrollment:

  1. Subjects must be at least 18 years of age;
  2. Non-smokers (<10 pack year history and no active smoking in the past year);
  3. Diagnosis of cystic fibrosis as via standard sweat chloride/phenotypic features/genotyping
  4. 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
  5. Baseline FEV1 >70% of predicted.
  6. No use of supplemental oxygen
  7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
  8. 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:

  1. Subjects must be at least 18 years of age;
  2. Non-smokers (<10 pack year history and no active smoking in the past year);
  3. Baseline FEV1 >70% of predicted.
  4. No use of supplemental oxygen or clinically significant lung disease
  5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
  6. Subjects must be willing and able to comply with scheduled visits and other trial procedures.

Exclusion Criteria:

  1. Active or past smokers with less than 1 years since quitting or >10 pack-year smoking history
  2. Co-existent asthma (as evidenced by either clinical diagnosis, chronic oral steroid use, or marked broncho-reactivity on pulmonary function testing)

  3. 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)
    • 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
  4. Unable to tolerate inhalation of gas mixture
  5. Any changes in medications that may affect CF lung disease in the past 14 days, including any experimental therapies
  6. 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.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 129Xe MRI
Participants 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.
Drug: Hyperpolarized Xenon gas

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.
Other Names:
  • 129Xe
Drug: PFP
  • 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.
Other Names:
  • Perfluoropropane gas (C3F8); 19F
Experimental: 19F MRI with PFP
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. 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.
Drug: Hyperpolarized Xenon gas

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.
Other Names:
  • 129Xe
Drug: PFP
  • 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.
Other Names:
  • Perfluoropropane gas (C3F8); 19F

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume of unventilated lung area after a single 129Xe inhalation and after each inhalation cycle with PFP
Time Frame: 1 hour
Primary comparison will be the VDP with Xenon (single breath) and after first PFP inhalation cycle (3 breaths of PFP)
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Signal-to-noise (SNR) of each modality
Time Frame: 20 minutes
Assessment of the quality of signal achieved with each modality
20 minutes
Rate constant describing wash-in and wash-out of PFP
Time Frame: 15 minutes
change in ventilated areas of the lung over time when administered PFP
15 minutes
Correlation between VDP identified by each modality and spirometry and Lung Clearance Index (LCI)
Time Frame: 2 hours
Comparison of VDP to two standard metrics of lung function, spirometry and LCI
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cystic Fibrosis Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Goralski, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-2569
  • XePFP2017 (Other Identifier: University of North Carolina at Chapel Hill)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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