Status:
COMPLETED
The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Cystic Fibrosis
Liver Fibroses
Eligibility:
All Genders
18+ years
Brief Summary
Cystic Fibrosis (CF) is a genetic condition which affects 1 in 2500 newborn infants and is the commonest genetic condition in the UK. 1 in 25 of the white population carry the mutation. The genetic de...
Eligibility Criteria
Inclusion
- Male or female \> 18 years of age
- Females will be non-pregnant and non-lactating\* (for MRI scan only)
- 20 patients with confirmed diagnosis of CF, 20 with CFLD and 20 healthy volunteers
- Women of childbearing potential (i.e. not surgically sterilised or \<1 year post menopause) will be required to:
- 1\. Confirm they are not currently breastfeeding 2. Undergo a serum pregnancy test (serum β-HCG)
Exclusion
- Contraindication to magnetic resonance imaging scanning (including claustrophobia) or gadolinium-based contrast agent
- eGFR \< 50 mL/min/1.73m2
- Pregnant or breast-feeding women.
- Any other condition, which in the opinion of the research team may put participants at risk during the study.
Key Trial Info
Start Date :
February 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT04277819
Start Date
February 15 2019
End Date
June 21 2023
Last Update
May 1 2024
Active Locations (1)
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1
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT