NCT01572064

Brief Summary

The main purpose of this pilot study is to evaluate non-invasive magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that the investigators can reduce the need of invasive techniques such as liver biopsy and transjugular hepatic venous portal pressure gradient (HVPG) measurements to assess the degree of liver scarring and portal hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

April 3, 2012

Last Update Submit

September 17, 2012

Conditions

Liver Fibrosis

Keywords

MRIliver biopsyserological markers

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with histology.

    MRI and MRS

    MRI within 3 months of liver biopsy

Secondary Outcomes (1)

  • Diagnostic accuracy of MRI in the detection of fibrosis and advanced fibrosis compared with serological markers.

    Blood Test taken on same day as MRI

Interventions

Blood samplePROCEDURE

1 fasted blood sample taken for metabolomics

MRI ScanOTHER

1 single visit for MRI and MRS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver biopsy within the last 3 months
  • Underlying chronic liver disease- hepatitis C, alcoholic liver disease, non-alcoholic fatty liver disease, hepatitis B, haemochromatosis or where biopsy is considered normal.
  • Ability to consent to participate in the study

You may not qualify if:

  • Inadequate biopsy length for histology
  • Absolute contraindications for MRI
  • Abdominal/waist circumference greater than 112 cm (44 inches), due to scanner bore constraints
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

  • Talwalkar JA, Yin M, Fidler JL, Sanderson SO, Kamath PS, Ehman RL. Magnetic resonance imaging of hepatic fibrosis: emerging clinical applications. Hepatology. 2008 Jan;47(1):332-42. doi: 10.1002/hep.21972.

    PMID: 18161879BACKGROUND

  • Fleming KM, Aithal GP, Solaymani-Dodaran M, Card TR, West J. Incidence and prevalence of cirrhosis in the United Kingdom, 1992-2001: a general population-based study. J Hepatol. 2008 Nov;49(5):732-8. doi: 10.1016/j.jhep.2008.05.023. Epub 2008 Jun 25.

    PMID: 18667256BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Blood Specimen CollectionMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Guruprasad P Aithal, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

May 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

GB(1)