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New treatment option for NASH - Nonalcoholic Steatohepatitis
Official title Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
ClinicalTrials.gov ID: NCT04054310
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and Female people 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
You likely can't join if
- 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:
See the full eligibility criteria
- Male and Female people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- New York, New York, United States
- Dallas, Texas, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States; New York, New York, United States; Dallas, Texas, United States; Charlottesville, Virginia, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.