Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02606487
• Date of registration: 13/11/2015
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations
• Scientific title: Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations
• Date of first enrolment: November 2015
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02606487
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: Felix Ratjen, MD PhD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of CF as defined by two or more clinical features of CF and a documented
sweat chloride > 60mEq/L by quantitative pilocarpine iontophoresis test or a genotype
showing two well characterized disease causing mutations

- Informed consent and verbal assent (as appropriate) provided by the subject's parent
or legal guardian and the subject

- Ages 8-18 years and able to perform reproducible spirometry and achieve a breath hold
duration sufficient for MRI acquisition

- 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.

Exclusion Criteria:

- Inability to perform reproducible pulmonary function tests (spirometry,
plethysmography or lung clearance index) or perform a breath-hold of sufficient
duration for MRI acquisition

- Medical instability that would preclude the ability to undergo the required
investigations

- FEV1 % predicted < 40%

- Use of supplementary oxygen

- Severe claustrophobia

- Pregnancy or lactation

- Presence of metal implants or other contraindications to MRI



Age minimum: 8 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Primary Outcome(s)

Ventilation Defect Percentage (VDP) [Time Frame: Pre-treatment]

Ventilation Defect Percentage (VDP) [Time Frame: Post-treatment - within 48h of completion of inpatient treatment]

Lung Clearance Index (LCI) [Time Frame: Pre-treatment]

Lung Clearance Index (LCI) [Time Frame: Post-treatment - within 48h of completion of inpatient treatment]

Secondary Outcome(s)

Pulmonary function tests (PFTs) [Time Frame: Post-treatment - within 48h of completion of inpatient treatment]

Pulmonary function tests (PFTs) [Time Frame: Pre-treatment]

Secondary ID(s)

1000049033

Source(s) of Monetary Support

Please refer to primary and secondary sponsors