The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    200
  • sponsor
    Manchester University NHS Foundation Trust
Updated on 27 February 2022
cancer
liver disease
liver transplant
genetic disorder
fibrosis
fibroscan
Accepts healthy volunteers

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 defect prevents the movement of fluids from cells, leading to thickened secretions and injury. With improvements in treatments from the commonest organ affected, the lungs, patients born with CF now can expect to live into their 40s with more than 60% living past 16.

Though better, more can be done. As treatments from lung complications have improved, the management of liver disease (second commonest organ involved) remains unchanged for a considerable time. Treatment options are limited with liver transplant the only curative option. Though potentially life-saving, it has risks and an organ shortage means alternative treatment options are desperately needed.

Identifying those with or at risk of Cystic Fibrosis related liver disease is difficult due to inadequate diagnostic tools. Routine blood tests are unreliable therefore specific blood tests to identify scarring of the liver (biomarkers) are urgently needed. Ultrasound scan, the recommended diagnostic investigation, is only accurate in identifying the late stages of liver disease. For new therapies to be most effective we need to be able to identify patients at a much earlier stage.

This study will use multi-modality testing, including imaging techniques such as FibroScan, MRI scan and blood tests (biomarkers), to diagnose those with liver scarring and use this to better categorise disease.

Details
Condition Cystic Fibrosis, Liver Fibroses, Cystic Fibrosis Liver Disease
Clinical Study IdentifierNCT04277819
SponsorManchester University NHS Foundation Trust
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Confirm they are not currently breastfeeding 2. Undergo a serum pregnancy test (serum -HCG)

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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