NCT04341246

Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH)

Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH): A Case-control Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Perspectum · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate to provide evidence to establish tightly defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or PDFF. The study will be divided into 2 sub groups comprising of cases and controls.

Detailed description

This is a prospective, case-control, study designed to measure the mean difference in cT1 and PDFF in patients who have undergone liver biopsy and have confirmed NASH and fibrosis or 'cases' (N=40) and N=20 patients with neither significant NASH nor significant fibrosis 'controls'. Confirmed cases will be patients who have met the criteria for active NASH with fibrosis according to the NAS CRN scoring system (NAS≥4 \& F2-3), 'controls' will be those who did not meet NASH diagnostic criteria and have evidence of fibrosis of ≤2. In addition, in order to investigate the variability of the biomarker investigators will assess the 'measurement' error in all participants by performing a repeat 'second' scan in the same scanning session, and , in cases only, 'biological' variability by performing a repeat scan in controls 2-4 weeks later. Suitable patients based on trial inclusion criteria will be identified by the study PI and clinical collaborator and invited to receive one or two MRI scans from which cT1 and PDFF will be derived using Perspectum's LiverMultiScan software. Baseline scan will ideally be performed between 3 days (to allow for recovery from the procedure and time for biopsy results to become available) and 6 weeks following biopsy, to minimize the likelihood that the patient is in a significantly different pathophysiologic state on the baseline scan day than on the biopsy day. In order to ensure that the investigators capture information on normal variability and not related to intervention they will also capture and record basic information at both measurement timepoints (e.g. body weight, waist circumference, details of lifestyle interventions).

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DEVICE	LiverMultiscan	The Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation

Timeline

• Start date: 2021-01-28
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2020-04-10
• Last updated: 2024-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study