Liver Multi Scan for Non-alcoholic Steatohepatitis

Recruiting at 6 trial locations

Overseen By Cayden Beyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Perspectum

Disqualifiers: NASH, Liver disease, Cirrhosis, Alcohol abuse, MRI issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a special liver scan, called Liver Multi Scan, can detect a liver condition known as NASH, which is severe liver inflammation not caused by alcohol. Participants will undergo this new scanning method to determine its accuracy in diagnosing NASH compared to traditional biopsies. Suitable candidates for the trial include individuals who may have fatty liver disease and have two or more conditions such as high liver enzymes, high blood pressure, diabetes, or high cholesterol. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance future diagnostic methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Liver Multi Scan is safe for diagnosing NASH?

Research has shown that LiverMultiScan is safe and gentle on the body. It uses an MRI scan, which is painless and requires no special tools or dye injections. Studies have found that LiverMultiScan accurately detects liver issues like NASH, a type of liver disease. This makes it a reliable alternative to more invasive methods like liver biopsies. No reports of serious side effects indicate it is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Liver Multi Scan because it offers a non-invasive way to assess liver health, which could be a game-changer for patients with non-alcoholic steatohepatitis (NASH). Unlike current standard methods, which often rely on invasive liver biopsies, this imaging technology provides a detailed picture of liver tissue without the need for surgery. This approach could make diagnosis and monitoring much easier and safer for patients, potentially leading to earlier detection and more personalized treatment plans.

What evidence suggests that the Liver Multi Scan is effective for diagnosing NASH?

Research has shown that LiverMultiScan, the investigational tool studied in this trial, effectively identifies patients with non-alcoholic steatohepatitis (NASH). Studies indicate that this scan uses MRI (magnetic resonance imaging) to measure specific liver markers, like cT1, which helps detect inflammation and scarring in the liver. LiverMultiScan has proven more reliable than other tests, especially for people with a high body mass index (BMI), and it has fewer failures compared to elastography, a common liver test. Overall, LiverMultiScan offers a promising way to assess liver health without needing a biopsy. ^{1 2 3 6 7}

Who Is on the Research Team?

Arun Sanyal, M.D.

Principal Investigator

VCU School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with suspected non-alcoholic fatty liver disease (NAFLD) who are scheduled for a liver biopsy and have risk factors like high body weight, diabetes, or abnormal blood fats. People with other chronic liver diseases, recent substance abuse, MRI contraindications like claustrophobia or metal implants, severe obesity, or certain medical conditions can't participate.

Inclusion Criteria

I am suspected of having NAFLD and have two or more risk factors like high liver enzymes, overweight, high blood pressure, type II diabetes, abnormal cholesterol levels.

Ability to understand and sign a written informed consent forms

I am scheduled for a liver biopsy using a specific needle size.

Exclusion Criteria

Participation in an investigational new drug (IND) trial in the 30 days before enrolment

I cannot have a liver biopsy.

I am scheduled for a specific liver biopsy procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Diagnostic Evaluation

Participants undergo MRI scans to evaluate cT1 and PDFF as diagnostic biomarkers for NASH

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for correlation between cT1, PDFF, and histopathological features of NASH

12 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Liver Multi Scan

Trial Overview

The N-QUAN trial is testing the 'Liver Multi Scan' technology to see how well it identifies patients with significant levels of both fat and scarring in their livers compared to standard biopsies. It's focused on those suspected of having NAFLD/NASH.

How Is the Trial Designed?

Group I: Study-gate Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Perspectum

Lead Sponsor

Trials

36

Recruited

13,600+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11920111/

Utility and cost-effectiveness of LiverMultiScan for MASLD ...

The primary outcome for this trial was to investigate the utility and cost-effectiveness of including multiparametric magnetic resonance ...

2.

perspectum.com

perspectum.com/our-products/livermultiscan

LiverMultiScan

Lower failure rates compared to elastography, even in high BMI. More robust compared to other tests in MASLD, MASH, and CLD patients.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1542356521010569

Clinical Utility of Magnetic Resonance Imaging Biomarkers ...

This study shows that quantitative MRI-derived biomarkers cT1 and liver fat are suitable for identifying patients with NASH, and cT1 is a better noninvasive ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2029349

Prospective Study of Outcomes in Adults with Nonalcoholic ...

In this prospective study involving patients with NAFLD, fibrosis stages F3 and F4 were associated with increased risks of liver-related complications and ...

5.

clinicaltrials.gov

clinicaltrials.gov/show/NCT03289897

Non-invasive Rapid Assessment of NAFLD Using Magnetic ...

This study will utilise LiverMultiScan and see if it can be the basis of a viable diagnostic pathway in EU healthcare systems by adopting it in different EU ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714423002756

Liver Investigation: Testing Marker Utility in Steatohepatitis ...

The primary objective is to identify non-invasive imaging modalities that accurately stage the severity of liver fibrosis in people with NAFLD, using liver ...

7.

perspectum.com

perspectum.com/our-company/news/livermultiscan-r-could-be-an-alternative-to-liver-biopsy-for-nash-clinical-trials

LiverMultiScan® could be an alternative to liver biopsy for ...

This study shows how one such test, LiverMultiScan, can accurately measure the hallmark disease characteristics of NASH using cT1 and PDFF that ...