Cystic Fibrosis Clinical Trial
Official title:
A Pilot Study to Assess the Use of MRI in the Assessment of Patients With Cystic Fibrosis and Primary Ciliary Dyskinesia
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.
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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