Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease

NCT02740868 | Recruiting Phase 2

• 1 other identifier: 1000048243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.

Conditions

Cystic Fibrosis; Asthma

Keywords

Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy

Outcome Measures

Primary Outcomes (1)

• Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement

  To evaluate image quality and reproducibility of 129Xe and inert fluorinated (19F) gas MRI and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.

  1 year

Study Arms (3)

Healthy

ACTIVE COMPARATOR

Healthy Participants ages 8 and older. Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Drug: Xenon-129 and Perfluoropropane (19F); Device: Magnetic Resonance Imaging; Device: Lung Clearance Index

Cystic Fibrisos

ACTIVE COMPARATOR

Participants with cystic fibrosis ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Drug: Xenon-129 and Perfluoropropane (19F); Device: Magnetic Resonance Imaging; Device: Lung Clearance Index

Asthma

ACTIVE COMPARATOR

Participants with asthma ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Drug: Xenon-129 and Perfluoropropane (19F); Device: Magnetic Resonance Imaging; Device: Lung Clearance Index

Interventions

Xenon-129 and Perfluoropropane (19F) DRUG

Xenon gas and perfluoropropane to be inhaled by research participants

Also known as: 129Xe and 19F

Asthma; Cystic Fibrisos; Healthy

Magnetic Resonance Imaging DEVICE

Lung imaging will be performed for participants using MRI for all 3 arms

Also known as: MRI

Asthma; Cystic Fibrisos; Healthy

Lung Clearance Index DEVICE

Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms

Also known as: LCI

Asthma; Cystic Fibrisos; Healthy

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants male and female aged 8 years old and older.
• Participants have no smoking history.
• For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
• Participants should have a FEV1%pred value greater than 40%.
• Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
• Participant must be able to perform a breath hold for 20s or less.
• Participant able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater).
• For the PEx sub-cohort, admission to the Hospital for Sick Children for a pulmonary exacerbation (based on clinical or pulmonary function assessment). Children who will be admitted and then discharged on home IV antibiotics may also be included in this study.

You may not qualify if:

• Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material.
• Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
• Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
• Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
• Participant is unable to perform spirometry or plethysmography maneuvers.
• Participant is pregnant or lactating.
• In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
• Participant has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio prosthetic, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (2)

• Munidasa S, Couch MJ, Rayment JH, Voskrebenzev A, Seethamraju R, Vogel-Claussen J, Ratjen F, Santyr G. Free-breathing MRI for monitoring ventilation changes following antibiotic treatment of pulmonary exacerbations in paediatric cystic fibrosis. Eur Respir J. 2021 Apr 15;57(4):2003104. doi: 10.1183/13993003.03104-2020. Print 2021 Apr. No abstract available.

  PMID: 33303537 DERIVED

• Kanhere N, Couch MJ, Kowalik K, Zanette B, Rayment JH, Manson D, Subbarao P, Ratjen F, Santyr G. Correlation of Lung Clearance Index with Hyperpolarized 129Xe Magnetic Resonance Imaging in Pediatric Subjects with Cystic Fibrosis. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1073-1075. doi: 10.1164/rccm.201611-2228LE. No abstract available.

  PMID: 28245140 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Asthma

Interventions

Xenon-129; perflutren; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Giles Santyr, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giles Santyr, PhD

CONTACT

416-813-7654; giles.santyr@sickkids.ca

Sharon Braganza, BSc

CONTACT

4167281662; sharon.braganza@sickkids.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: April 15, 2016
• Study Start: August 1, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)