An interventional study of Liver Multi Scan in NASH - Nonalcoholic Steatohepatitis, sponsored by Perspectum. Recruiting at 7 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Perspectum · Not applicable, Interventional, and Diagnostic
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.
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 fibrosis could not improve, and the data to support fibrosis being predictive of clinical outcomes. As a result, many clinical trials now require patients to have a NAS ≥4 or 5, with the regulatory accepted criteria requirement for at least a score of 1 for inflammation and 1 for ballooning, and evidence of fibrosis of stage 2 or more (scored using the Kleiner-Brunt (0-4) scale). The route by which a liver biopsy is indicated for inclusion to a clinical trial is usually based on patient presentation and clinical work-up. In the Primary care patient presents with clinical risk factors for NASH like metabolic syndrome. Blood biomarkers will be checked and if raised patient will be referred to the hepatology. In the secondary care patient might have a transient elastography and if CAP is equal or more than 280 and LSM is equal or more than 7 kPa, patient will have biopsy.
However clinical risk factors are often not sensitive enough, and NASH trials often suffer from high levels of screen fails at biopsy, meaning a large proportion are unnecessarily biopsied. Screening strategies are becoming increasingly more popular in order to reduce the number that fail screening and metrics derived from magnetic resonance imaging (MRI) such as T1-mapping and PDFF are emerging as promising diagnostic screening biomarkers in NASH.
MRI exploits the magnetic properties of hydrogen nuclei protons within a determined magnetic field. T1 mapping measures longitudinal relaxation time, a measure of how long it takes for protons to re-equilibrate their spins to the magnetic field after being excited by a radiofrequency pulse, and thus is an indicator of regional tissue water (proton) content. T1 mapping has shown promise as an effective biomarker of liver inflammation and fibrosis, as T1 relaxation time lengthens with increases in extracellular fluid (which may be caused by fibrosis and/or inflammation). The presence of iron however, which can be accurately measured from MRI-T2star (T2*) relaxation time, shortens the T1, and thus must be accounted for. An algorithm has been created (Perspectum Diagnostics) that allows for the bias introduced by elevated iron to be removed from the T1 measurements, yielding the iron corrected T1 (cT1). Iron corrected T1 (cT1) has been shown to correlate with fibro-inflammatory disease and can effectively stratify patients with NASH and cirrhosis (7).
MRI-PDFF is a ratio, expressed as a percentage, of the fraction of the MRI-visible protons attributable to fat divided by all MRI-visible protons in that region of the liver attributable to fat and water. Taking advantage of the chemical shift between fat and water, pulse sequences including fast spin echo and gradient-recalled echo (GRE) sequences can be used to acquire images at multiple echo times at which fat and water signals have different phases relative to each other. PDFF has been shown to have excellent correlation between histologically graded steatosis across the clinical range seen in NASH and high diagnostic accuracy in stratification of all grades of liver steatosis, although it is weaker in the presence of advanced fibrosis. Whilst PDFF does not correlate with other features of NASH, it has been reported that NAFLD patients with grade one steatosis are more likely to have characteristics of advanced liver disease such as fibrosis and ballooning, and changes in hepatic steatosis may be correlated with changes in other histological endpoints. Thus whilst some authors advise caution about using PDFF as a biomarker of NASH it has been well accepted by the NASH community as a biomarker for both enrolment and as an endpoint in NASH clinical trials (e.g. MOZART: NCT01766713; FLINT: NCT01265498).
Where cT1 appears to have an advantage over PDFF as a non-invasive biomarker for NASH, is in detection of patients with both disease activity (ballooning and inflammation) and fibrosis as cT1 has been reported to be correlated with ballooning, fibrosis and NAFLD activity score, and has been shown to predict clinical outcomes. As such it is emerging as a promising biomarker for both screening and as an endpoint in NASH clinical trials (NCT02421094; NCT02912260) particularly those investigating mechanisms of action of fibro-inflammation, or for distinguishing those with more advanced NASH with fibrosis. Both cT1 and PDFF can be acquired as part of the LiverMultiScan™ (LMS) imaging protocol (Perspectum Diagnostics Ltd, UK).
Based on the data reported in the literature, and from our preliminary analysis of N=109 biopsy-confirmed NAFL patients recruited from the two UK studies, both cT1 and PDFF appear to have potential to become diagnostic biomarkers, that may have utility for clinical trial population enrichment when used in conjunction with clinical risk factors. Specifically, for PDFF to identify participants who are more likely to have histopathologic findings of steatosis, and cT1 to identify participants who are more likely to have histopathologic findings of NASH, and NASH with fibrosis.
The primary objective of this study is to evaluate cT1 (Corrected T1) as a diagnostic biomarker that can be used, in conjunction with clinical risk factors, to identify patients who are more likely to have liver histopathologic findings of non-alcoholic steatohepatitis (NASH). Ideally, this biomarker should identify patients with a non-alcoholic fatty liver disease activity score (NAS) ≥ 4 and liver fibrosis (NASH/CRN Brunt/Kleiner scale) ≥ stage 2 on histopathologic assessment.
Based on our observations from earlier trials, our hypothesis is that we expect cT1 to have good diagnostic accuracy for discriminating those with NAS≥4 \& F≥2 from those without
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 225 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Perspectum is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm of biopsy naïve participants suspected of having NAFLD or NASH, who have been referred for a liver biopsy as part of routine clinical care
Diagnostic Test: Liver Multi Scan
MRI to create cT1, T2\* and PDFF images of patients liver.
Also known as: Biopsy
Diagnostic performance of cT1
To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 \& F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.
Time frame: 12 months
Diagnostics performance of PDFF
To evaluate, inpatients with suspected NASH referred for liver biopsy, the diagnostic performance of PDFF at discriminating those with NAS≥4 from those without, and those with Brunt Steatosis≥2 from those without. The diagnostic performance will be determined using area under the receiver operative curve (AUROC) analysis.
Time frame: 12 months
Correlation between cT1 and hisopathological features
To assess the correlation between cT1 and histopathological features of NASH and PDFF and histopathological features of NASH. The correlations will be explored using Spearman's Rho
Time frame: 12 months
Not enrolling at this site.
Plan to share: No
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Non-alcoholic Fatty Liver Disease →