Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study
Perspectum
Summary
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.
Description
NASH trials will often use the criteria proposed by the NASH Clinical Research Network (NASH-CRN), the NAS scoring system, to classify patients as suitable for study enrolment. NAS is a summation of the histology scores for fat (0-3), inflammation (0-3), and ballooning (0-2) with a score of 4 or 5 or higher regarded as NASH. Whilst the score doesn't include fibrosis, the rapidly evolving clinical trials landscape in NASH has seen a shift in emphasis from drugs proposed to target liver fat to the targeting of fibrosis. This was due to observations contrary to the previously held belief that fib…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and Female subjects aged between 18 and 75 years old * Ability to understand and sign a written informed consent forms * Patients scheduled to undergo a standard of care diagnostic liver biopsy as follows * Percutaneous biopsy with a 16 gauged needle passed into the right lobe * Trans-jugular biopsy with an 18 gauged needle passed into the right lobe * Patients who are suspected of having NAFLD, who are being considered for treatment, and presenting with two or more of the following risk factors for NASH * Elevated liver enzymes (ALT≥40) * BMI≥25kG/m\^2 * Hypertensi…
Interventions
- Diagnostic TestLiver Multi Scan
MRI to create cT1, T2\* and PDFF images of patients liver.
Locations (7)
- Arizona Liver HealthChandler, Arizona
- RUSH University Medical CenterChicago, Illinois
- Indiana University HealthIndianapolis, Indiana
- Icahn School of Medicine at Mount SinaiNew York, New York
- Liver Center of TexasDallas, Texas
- University of VirginiaCharlottesville, Virginia