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Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations

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ClinicalTrials.gov Identifier: NCT02606487
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children

Brief Summary:
The investigators aim to assess whether pulmonary MRI (hyperpolarised 129Xe ventilation imaging [Xe-MRI]) can detect changes in ventilation defects in patients with CF before and after treatment for a pulmonary exacerbation. The investigators will determine whether changes seen using pulmonary Xe-MRI are associated with changes in pulmonary function (spirometry, lung volumes, lung clearance index [LCI]) in patients with CF before and after pulmonary exacerbation.

Condition or disease
Cystic Fibrosis

Detailed Description:

Cystic fibrosis (CF) is one of the most common genetic diseases affecting children and young adults [1]. Lung disease is the primary cause of morbidity and mortality in these patients and sensitive markers of lung disease in CF are important for directing therapy in these patients.

LCI, measured by multiple breath washout (MBW), has been shown to be more sensitive than traditional pulmonary function tests (PFTs) for assessing the treatment effect of novel therapies in CF patients [2,3]. However, LCI provides no information regarding the spatial distribution of ventilation inhomogeneity within the lungs and improvements in mucus plugging of poorly ventilated regions can paradoxically worsen the LCI [4,5]. Thus an imaging technique that can capture regional changes in the distribution of ventilation might be better suited than LCI to detect treatment effects and could also help to better define the utility of LCI as a clinical tool.

Xe-MRI is a safe, non-ionizing modality for imaging the lungs, providing an accurate spatial representation of ventilation inhomogeneity [6]. Xe-MRI has been shown to be effective in imaging of adult patients with chronic obstructive pulmonary disease (COPD) and CF [6] however, there are no published studies using Xe-MRI in children.

The hypothesis of this study is that Xe-MRI and LCI will provide complimentary information when quantifying ventilation inhomogeneity in CF lung disease and that Xe-MRI will be able to define patients in whom LCI fails to capture positive effects of treatment. The ultimate goal is to develop more sensitive tools for longitudinal monitoring to direct the clinical care of CF patients in the future.

To accomplish this, the investigators will compare the ability of Xe-MRI and LCI to detect changes in ventilation inhomogeneity in patients with CF before and after treatment for a pulmonary exacerbation, a common pulmonary complication of CF.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations
Study Start Date : November 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Xenon

Group/Cohort
CF pulmonary exacerbation group
Patients with cystic fibrosis admitted for inpatient treatment of a pulmonary exacerbation



Primary Outcome Measures :
  1. Ventilation Defect Percentage (VDP) [ Time Frame: Pre-treatment ]
    VDP within 48h of initiation of inpatient treatment

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

  3. Lung Clearance Index (LCI) [ Time Frame: Pre-treatment ]
    LCI within 48h of initiation of inpatient treatment

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


Secondary Outcome Measures :
  1. Pulmonary function tests (PFTs) [ Time Frame: Pre-treatment ]
    PFTs within 48h of initiation of inpatient treatment

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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged 8-18 with cystic fibrosis admitted for inpatient treatment with a clinical diagnosis of pulmonary exacerbation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606487


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Felix Ratjen, MD PhD The Hospital for Sick Children
Publications:

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Responsible Party: Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02606487    
Other Study ID Numbers: 1000049033
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Keywords provided by Felix Ratjen, The Hospital for Sick Children:
CF
Exacerbation
Hyerpolarized xenon MRI
Pediatrics
Lung Clearance Index
Additional relevant MeSH terms:
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Cystic Fibrosis
Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases