Smart Imaging for Accelerated Liver Disease Trials

NASH & NAFLD

We offer a turn-key medical imaging solution for clinical trials in non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). Get quantitative, standardized insight into total patient health with our robust, quantitative biomarkers and AI-driven digital pathology services.

Metrics

Liver Fat (MRI-PDFF)

Fibro-inflammation (cT1)

Liver Stiffness (MRE)

Digital Pathology

Clinical Research Opportunity

Imaging can be easily incorporated into phase I, II, and III NASH clinical trials to de-risk trial design and reduce costs through enhanced trial enrichment, early efficacy detection, and longitudinal monitoring.

Accelerate patient recruitment by leveraging our global imaging centre network to quickly and cost-effectively find the right NASH patients most likely to benefit from treatment.

Non-invasive, Quantitative Metrics of Liver Health

Our cutting-edge, multiparametric MRI technology capabilities allow us to non-invasively characterise liver health by providing comprehensive measurements of liver fat, iron concentration, fibro-inflammation, and more.

cT1 and MRI-PDFF have both been shown to have high correlation with histological results of fibrosis, inflammation and steatosis.1,2,3,4,5Additionally, cT1 has been shown to reliably predict liver-related clinical outcomes.2

Full-Service Offering

Comprehensive Patient Health

Multi-organ Characterisation:
Liver, kidneys, pancreas, spleen, heart, aorta, biliary tree, colon, body composition, and bone mineral density

Imaging Technologies include:
MRI, Computerised tomography (CT), positron emission tomography (PET), DXA, endoscopy, and digital pathology

Enhanced Patient Screening

Reduce the screen fail rate, improve the patient experience, and lower trial costs by pre-screening with our best-in-class imaging biomarkers before initial biopsy.

The histological features that contribute to steatohepatitis, including liver fat, fibrosis, and inflammation, can be characterised by measuring PDFF and cT1.1,2,3  Clinical studies have shown that cT1 helps effectively stratify NASH populations and enrich for patients with F2/3 fibrosis.6

Standardised and Reproducible Results

Our biomarkers have excellent reproducibility and repeatability7 with diagnostic accuracy that is superior to others. This enables more reliable monitoring of disease progression as a response to treatment and allows smaller trials to be run with more confidence.

Biomarker

Regulatory clearance

Biomarker qualification

Type

Diagnostic accuracy (95% CI)

PRO-C3

None

LOI accepted into BQP May 2020

Blood

 

NAFLD vs NAFLD & F≥3

0.81 (0.74–0.87)8

NIS-4

None

LOI accepted into BQP Feb 2020

Blood

NAFLD vs NASH with Fibrosis

0.82 (0.78 – 0.85)9

ELF

CE marked

LOI accepted into BQP Feb 2020

Blood

NAFLD/ Healthy vs NAFLD with activity

0.77 (0.67 -0.88)10

OWL

CE marked

LOI accepted into BQP Feb 2020

Blood

NASH vs NAFLD

0.88 (0.85-0.91)11

FibroTest

FDA and CE approvals not required

No

Blood

Not reported

cT1

FDA cleared and CE marked

FDA BQP Full QP submitted Oct 2019

Imaging

NAFLD/ Healthy vs NAFLD with activity

0.89 (0.83 – 0.95)10

PDFF

FDA cleared and CE marked

FDA BQP Full QP submitted Oct 2019

Imaging

NAFLD/ Healthy vs NAFLD with activity

0.72 (0.59 – 0.84)12

MRE

FDA cleared and CE marked

No

Imaging

NAFLD vs NASH

0.70 (0.57 – 0.82)13

LSM-Fibroscan

FDA cleared and CE marked

LOI accepted into BQP May 2020

Imaging

NAFLD/ Healthy vs NAFLD with activity

0.85 (0.76–0.93)10

 

Our proprietary technology corrects for iron content, field strength, and manufacturer differences to deliver a “corrected T1”. This allows more robust metrics to be collected to support multi-site trials.

Digital Pathology

Our standardised approach to biopsy processing and staining combined with our AI-driven, objective scoring systems decrease slide heterogeneity and reduce inter-/intra-reader variability.

Ballooning

Ballon cell count Balloon cell size and density

Fibrosis Characterisation

Peri-cellular fibrosis

Fibrosis Characterisation

Bridging fibrosis

Magnetic Resonance Elastography (MRE)

MRE is another useful tool to provide supplementary assessment of fibrosis stage by liver stiffness. Our proven MR-imaging expertise enables us to provide the highest quality MRE metrics with superior accuracy and reproducibility.

Low Fibrosis

Mean Liver Stiffness: 1.69 kPa

High Fibrosis

Mean Liver Stiffness: 5.4 kPa

Central Imaging Service

We receive raw images acquired by our trained imaging centers and analyse them using proprietary artificial intelligence and machine learning algorithms.

All images are checked for quality, and every report undergoes a review process prior to return. Our Perspectum Portal performs a single platform for access to data and results.

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