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Diagnostic Test

Liver Multi Scan for Non-alcoholic Steatohepatitis

N/A
Recruiting
Led By Arun Sanyal, M.D.
Research Sponsored by Perspectum
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, Hypertension, Type II diabetes, Dyslipidameia, Low High-density lipoprotein (HDL) (<40mg/dl in men or <50mg/dl in women), Hypertriglyceridemia (≥150mg/dl), Hypercholestrolemia (≥200mg/dl), Triglycerides (TG)/HDL>5.0
Male and Female subjects aged between 18 and 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether CT1 can help distinguish patients with suspected NASH who have NAS≥4 & F≥2 from those without.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves a Liver Multi Scan which is an imaging technique similar to an MRI scan, there are generally no direct side effects from the scan itself. However, discomfort due to lying still during scanning may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
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I am between 18 and 75 years old.
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I am scheduled for a liver biopsy using a specific needle size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic performance of cT1
Secondary outcome measures
Correlation between cT1 and hisopathological features
Diagnostics performance of PDFF

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study-gateExperimental Treatment1 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

Find a Location

Who is running the clinical trial?

PerspectumLead Sponsor
34 Previous Clinical Trials
13,370 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
1,600 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Arun Sanyal, M.D.Principal InvestigatorVCU School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
RUSH University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~5 spots leftby May 2024