Status:
RECRUITING
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
Lead Sponsor:
Perspectum
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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.
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- Prior histopathological diagnosis of NASH
- Inability to undergo a liver biopsy
- Prior or planned liver transplantation
- Patient scheduled to undergo a laparoscopic or wedge liver biopsy or biopsy taken from the left lobe
- Participation in an investigational new drug (IND) trial in the 30 days before enrolment
- Other known causes of chronic liver disease based on clinical criteria at the study site such as the following:
- Alcoholic liver disease
- Primary biliary cirrhosis
- Primary sclerosing cholangitis
- Autoimmune Hepatitis
- Wilson's disease, hemochromatosis, iron overload
- Alpha/1/Antitrypsin (A1AT) deficiency
- HCV, HBV
- History or diagnosis of cirrhosis and or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Clinically relevant drug or alcohol abuse within 12 months of screening
- Any contradiction or significant limitation to MRI scanning
- Claustrophobia preventing MR imaging (requires 15-30 minutes in scanning)
- Pacemaker or another implanted device
- Metal in body (such as an aneurysm clip) that might produce artefacts on abdominal MRI or might be adversely impacted by a high magnetic field
- Inability to lie flat, remain still or briefly hold breath as necessary during MR imaging
- Medical condition likely to produce significant hypervolemia like congestive heart failure
- Severe obesity complicating positioning in MR scanner
- Weight reduction surgery within 3 years
- Concomitant medical illnesses per investigators discretion (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer
- Clinically significant medical or psychiatric condition considered a high risk participation in an investigational study
- Failure to give informed consent
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04054310
Start Date
August 5 2020
End Date
February 1 2026
Last Update
December 1 2025
Active Locations (7)
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1
Arizona Liver Health
Chandler, Arizona, United States, 85224
2
RUSH University Medical Center
Chicago, Illinois, United States, 60612
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029