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Non-Invasive Quantification of Liver Health in NASH (N-QUAN)

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ClinicalTrials.gov Identifier: NCT04054310
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Diagnostic Test: Liver Multi Scan Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Study arm
Only one arm, so not necessary.
Diagnostic Test: Liver Multi Scan
MRI to create cT1, T2* and PDFF images of patients liver.
Other Name: Biopsy




Primary Outcome Measures :
  1. Diagnostic performance of cT1 [ Time Frame: 12 months ]
    To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 & F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.


Secondary Outcome Measures :
  1. Diagnostics performance of PDFF [ Time Frame: 12 months ]
    To evaluate, inpatients with suspected NASH referred for liver biopsy, the diagnostic performance of PDFF at discriminating those with NAS≥4 from those without, and those with Brunt Steatosis≥2 from those without. The diagnostic performance will be determined using area under the receiver operative curve (AUROC) analysis.

  2. Correlation between cT1 and hisopathological features [ Time Frame: 12 months ]
    To assess the correlation between cT1 and histopathological features of NASH and PDFF and histopathological features of NASH. The correlations will be explored using Spearman's Rho



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054310


Contacts
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Contact: Arun Sanyal 804-828-4060 arun.sanyal@vcuhealth.org
Contact: Andrea Dennis 01865655343 andrea.dennis@perspectum.com

Locations
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United States, Virginia
Virginia Common wealth University Not yet recruiting
Richmond, Virginia, United States, 23284
Contact: Arun Sanyal, MD    804-828-4060    arun.sanyal@vcuhealth.org   
Contact: Rebecca Collen, BSC    8048280100    rebeccs.collen@vcuhealth.org   
Sponsors and Collaborators
Perspectum Diagnostics Ltd

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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT04054310     History of Changes
Other Study ID Numbers: IIP137
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics