NCT04054310 · Perspectum
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
Where
- Chandler, Arizona
- Chicago, Illinois
- Indianapolis, Indiana
- New York, New York
- Dallas, Texas
- Charlottesville, Virginia
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations