Liver Multi Scan for Non-alcoholic Steatohepatitis
Recruiting in Palo Alto (17 mi)
+6 other locations
AS
Overseen byArun Sanyal, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Perspectum
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
AS
Arun Sanyal, M.D.
Principal Investigator
VCU School of Medicine
Eligibility Criteria
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.
I am between 18 and 75 years old.
Ability to understand and sign a written informed consent forms
See 1 more
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.
See 3 more
Treatment Details
Interventions
- Liver Multi Scan (Diagnostic Test)
Trial OverviewThe 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.
Participant Groups
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
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Who Is Running the Clinical Trial?
Perspectum
Lead Sponsor
Trials
36
Recruited
13,600+