MRI in Cystic Fibrosis and Primary Ciliary Dyskinesia

NCT ID: NCT03279965

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-05

Study Completion Date

2018-05-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cystic Fibrosis Primary Ciliary Dyskinesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cystic fibrosis

Patients with known cystic fibrosis

MRI

Intervention Type DIAGNOSTIC_TEST

MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)

Primary ciliary dyskinesia

Patients with known primary ciliary dyskinesia

MRI

Intervention Type DIAGNOSTIC_TEST

MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)

Interventions

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MRI

MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Nuclear magnetic resonance (NMR)

Eligibility Criteria

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Inclusion Criteria

* Known CF or PCD Referred for CT chest

Exclusion Criteria

* Contraindication to MRI (Pacemaker etc) Unable to stay still for MRI
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioxydyn Ltd, Manchester

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anand Devaraj

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton Hospital, London

Locations

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Royal Brompton Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Anand Devaraj

Role: CONTACT

02073528121

Thomas Semple, MBBS, BSc

Role: CONTACT

02073528121

Facility Contacts

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Thomas Semple, FRCR MBBS

Role: primary

02073528121

Anand Devaraj

Role: backup

02073528121

Other Identifiers

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2016LI002B

Identifier Type: -

Identifier Source: org_study_id

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