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Trial record 8 of 1233 for:    cystic fibrosis

MRI in Cystic Fibrosis and Primary Ciliary Dyskinesia

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ClinicalTrials.gov Identifier: NCT03279965
Recruitment Status : Unknown
Verified September 2017 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
Bioxydyn Ltd, Manchester
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:

This is a small pilot / feasibility study (Approximately 50 patients) to assess the possibility of clinical implementation of MRI assessment of patients with cystic fibrosis and primary ciliary dyskinesia.

Patients will undergo their standard CT imaging and lung function investigations and additionally will undergo MRI examination. Reports from CT (the current gold standard) and MRI will be assessed for concordance and patient acceptability and examination implementation costs will also be assessed. Novel MRI-based potential markers of CF and PCD disease state will also be assessed.


Condition or disease Intervention/treatment
Cystic Fibrosis Primary Ciliary Dyskinesia Diagnostic Test: MRI

Detailed Description:

In this small single site pilot / feasibility study we aim to recruit approximately 50 patients over the age of 6 years with known cystic fibrosis (CF) or primary ciliary dyskinesia (PCD).

Patients will be recruited from routine clinic appointments or at admission for inpatient investigation and/or treatment at the point of referral for computed tomography (CT) examination. If they consent to participation they will undergo MRI examination in addition to their standard clinical CT (within 7 days of the CT scan - on the same day if practicable).

The magnetic resonance imaging (MRI) scans will be anonymised and reported by radiologists, blinded to the CT findings. The reports and scores (Eichinger and Brody2) will then be compared those of the standard CT to assess concordance between the modalities and inter and intra observer variability.

Potential novel biomarkers (pulmonary ventilation and perfusion (non-contrast) and sinus mucus and liver tissue characteristics) will be compared with established markers (including lung clearance index) and known CF mutation / PCD type.

Patients or their carers will also be asked to fill in a short questionnaire comparing the differential patient acceptability of CT and MRI examinations. The cost (time, resources etc) of each examination will be calculated and compared.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Assess the Use of MRI in the Assessment of Patients With Cystic Fibrosis and Primary Ciliary Dyskinesia
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : May 5, 2018
Estimated Study Completion Date : May 5, 2018


Group/Cohort Intervention/treatment
Cystic fibrosis
Patients with known cystic fibrosis
Diagnostic Test: MRI
MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)
Other Name: Nuclear magnetic resonance (NMR)

Primary ciliary dyskinesia
Patients with known primary ciliary dyskinesia
Diagnostic Test: MRI
MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)
Other Name: Nuclear magnetic resonance (NMR)




Primary Outcome Measures :
  1. Structural and quantitative MRI vs CT in cystic fibrosis and primary ciliary dyskinesia assessment [ Time Frame: 18 months ]
    To determine whether MRI with ventilation imaging can produce sufficiently diagnostic images, in the setting of CF or PCD, to replace CT imaging follow up. This will be assessed via semi-quantitative visual scoring (CT-based Brody / CFCT score and MRI-based Eichinger score) with both scoring systems applied to both CT and MRI. Scoring of the "air-trapping" component of CFCT will be substituted with scoring of ventilation defects on MRI. Scores will come from 2 observers, blinded to each others opinion, with a 3rd observer acting to resolve discrepancies. Intermodality variation will be assessed via ICC and Bland-Altman


Secondary Outcome Measures :
  1. Ventilation MRI vs Lung clearance index (LCI) [ Time Frame: 18 months ]
    Dynamic oxygen enhanced MRI measures will be compared to equivalent measurements from lung clearance testing. Bland Altman and ICC analysis of time to oxygen wash in (in seconds) on MRI, to time to nitrogen washout in seconds from lung clearance testing

  2. Sinus disease and exacerbations 1 [ Time Frame: 18 months ]
    Simple correlative statistics of degree of sinus opacification (percentage volume occupied by mucus and polyps) with frequency of infective exacerbations (number per month)

  3. Sinus disease and exacerbations 2 [ Time Frame: 18 months ]
    Simple correlative statistics of degree of sinus opacification (percentage volume occupied by mucus and polyps) with rate of decline in spirometry measures (percentage drop in predicted FEV1 and FEV1/FVC over the 6 months prior to scanning)

  4. Sinus disease and exacerbations 3 [ Time Frame: 18 months ]
    Simple correlative statistics of presence of susceptibility artefact in sinus mucus (binary; yes, no) with micro-organism cultured (nominal)

  5. Liver disease 1 [ Time Frame: 18 months ]
    Simple correlation of liver volume (cm3) and T1 relaxation time (ms) with serologic markers of liver function (AST, ALT and ALP in IU/L and albumin in g/L)

  6. Liver disease 2 [ Time Frame: 18 months ]
    Simple correlation of liver T1 relaxation time (ms) with ultrasound elastography markers of liver fibrosis (sheer wave speed in m/s)

  7. Patient acceptability [ Time Frame: 18 months ]
    To determine whether MRI is as acceptable to patients with CF or PCD as CT. This is via simple descriptive statistics from a bespoke questionnaire consisting of 5-point Likert scale questions regarding each scan.

  8. Clinical implementation [ Time Frame: 18 months ]
    To determine the operational cost differences in implementing MRI follow up vs CT follow up. Simple comparison of cost (in GBP) of diagnostic CT vs lung MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with known cystic fibrosis or primary ciliary dyskinesia referred for CT chest as part of routine outpatient or inpatient investigations.
Criteria

Inclusion Criteria:

  • Known CF or PCD Referred for CT chest

Exclusion Criteria:

  • Contraindication to MRI (Pacemaker etc) Unable to stay still for 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): NCT03279965


Contacts
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Contact: Anand Devaraj 02073528121 A.Devaraj@rbht.nhs.uk
Contact: Thomas Semple, MBBS, BSc 02073528121 T.Semple@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Thomas Semple, FRCR MBBS    02073528121    T.Semple@rbht.nhs.uk   
Contact: Anand Devaraj    02073528121    A.Devaraj@rbht.nhs.uk   
Principal Investigator: Anand Devaraj         
Sub-Investigator: Simon Padley         
Sub-Investigator: Thomas Semple         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Bioxydyn Ltd, Manchester
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Anand Devaraj Royal Brompton Hospital London

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03279965     History of Changes
Other Study ID Numbers: 2016LI002B
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data outside the research team at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Lung MRI cystic fibrosis primary ciliary dyskinesia
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Ciliary Motility Disorders
Kartagener Syndrome
Dyskinesias
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Bronchiectasis
Bronchial Diseases
Respiratory System Abnormalities
Dextrocardia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Situs Inversus