NCT02606487|Completed
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Sponsor study identifier
observational
21
1 country
1
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2017
Actual (reported)Study Completion
November 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 13, 2015
Actual (reported)November 17, 2015
Actual (reported)November 2017
Actual (reported)November 2017
Actual (reported)Ventilation Defect Percentage (VDP)
VDP within 48h of initiation of inpatient treatment
Pre-treatment
Ventilation Defect Percentage (VDP)
VDP within 48h of completion of inpatient treatment
Post-treatment - within 48h of completion of inpatient treatment
Lung Clearance Index (LCI)
LCI within 48h of initiation of inpatient treatment
Pre-treatment
Lung Clearance Index (LCI)
LCI within 48h of completion of inpatient treatment
Post-treatment - within 48h of completion of inpatient treatment
Pulmonary function tests (PFTs)
Pre-treatment
Pulmonary function tests (PFTs)
Post-treatment - within 48h of completion of inpatient treatment
Patients with cystic fibrosis admitted for inpatient treatment of a pulmonary exacerbation
Patients aged 8-18 with cystic fibrosis admitted for inpatient treatment with a clinical diagnosis of pulmonary exacerbation
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
O'Sullivan BP, Freedman SD. Cystic fibrosis. Lancet. 2009 May 30;373(9678):1891-904. doi: 10.1016/S0140-6736(09)60327-5. Epub 2009 May 4.
Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
Felix Ratjen, MD PhD
The Hospital for Sick Children
21 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2015
First Posted
November 17, 2015
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Contact the study team to confirm eligibility.
Davies J, Sheridan H, Bell N, Cunningham S, Davis SD, Elborn JS, Milla CE, Starner TD, Weiner DJ, Lee PS, Ratjen F. Assessment of clinical response to ivacaftor with lung clearance index in cystic fibrosis patients with a G551D-CFTR mutation and preserved spirometry: a randomised controlled trial. Lancet Respir Med. 2013 Oct;1(8):630-638. doi: 10.1016/S2213-2600(13)70182-6. Epub 2013 Sep 10.
Horsley AR, Davies JC, Gray RD, Macleod KA, Donovan J, Aziz ZA, Bell NJ, Rainer M, Mt-Isa S, Voase N, Dewar MH, Saunders C, Gibson JS, Parra-Leiton J, Larsen MD, Jeswiet S, Soussi S, Bakar Y, Meister MG, Tyler P, Doherty A, Hansell DM, Ashby D, Hyde SC, Gill DR, Greening AP, Porteous DJ, Innes JA, Boyd AC, Griesenbach U, Cunningham S, Alton EW. Changes in physiological, functional and structural markers of cystic fibrosis lung disease with treatment of a pulmonary exacerbation. Thorax. 2013 Jun;68(6):532-9. doi: 10.1136/thoraxjnl-2012-202538. Epub 2013 Feb 9.
Yammine S, Bigler A, Casaulta C, Singer F, Latzin P. Reasons for heterogeneous change in LCI in children with cystic fibrosis after antibiotic treatment. Thorax. 2014 Feb;69(2):183. doi: 10.1136/thoraxjnl-2013-204283. Epub 2013 Aug 29. No abstract available.
Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15.
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.
Primary Completion
November 2017
Actual (reported)Study Completion
November 2017
Actual (reported)Last Updated
October 4, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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