The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF

NCT04682600 | Unknown FDA Device

• 1 other identifier: SI-CLIN-02
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects. Specifically, the investigators are comparing MRE and FibroScan to Vibroelastography (VE, Liver Incytes System). These techniques are used to measure stiffness in the liver.

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD); Non-Alcoholic Steatohepatitis (NASH); Liver Fibroses; Liver Steatoses

Keywords

NASH; NAFL; NAKLD; Liver; Elastography; Ultrasound

Outcome Measures

Primary Outcomes (2)

• Elasticity measurements comparison between Liver Incytes MR Elastography

  Elasticity measurements (kPa) from the Liver Incytes system and the MR system will be compared to determined whether the reported stiffness of the tissue (mean and 95% confidence intervals) are equivalent by concordance correlation coefficient and 95% confidence intervals.

  12 months

• Determination of Liver Incytes' discriminatory ability of liver stiffness as measured by fibrosis staging

  Liver Incytes liver stiffness values will be compared to values obtained using MRE to determine the cutoff values for the Liver Incytes System for each level of fibrosis staging. For each stage of fibrosis as defined by MRE, Area Under the Receiver Operating Curve (AUROC) for Liver Incytes elasticity will be calculated and the cutoff maximizing the sensitivity and specificity will be determined.

  12 months

Secondary Outcomes (5)

• Attenuation measurements comparison between the Liver incytes System and MRI Proton Density Fat Fraction

  12 months

• Comparison between Liver Incytes' and FibroScan's fibrosis staging capabilities

  12 months

• Comparison between Liver Incytes' and FibroScan's steatosis staging capabilities

  12 months

• Incidence of and Device Deficiencies

  12 months

• Incidence of Adverse Events

  12 Months

Other Outcomes (6)

• Identification of cases in which FibroScan may overestimate or underestimate liver stiffness

  12 months

• Identification of cases in which FibroScan may overestimate or underestimate fat content

  12 months

• Liver Incytes System User Experience Survey

  12 months

Study Arms (1)

Open-label

EXPERIMENTAL

Volunteers who have agreed to participate in the study will have their liver scanned using the FibroScan, VE (Liver Incytes System) and MRE techniques.

Device: Liver Incytes System

Interventions

Liver Incytes System DEVICE

The Liver Incytes System uses the Shear Wave Absolute Vibro-Elastrography (S-WAVE) method. The imaging procedure of the Liver Incytes system is similar to a traditional ultrasound scanning procedure or FibroScan, in which the patient is asked to lie supine on an examination bed, with the operator seated next to them. A vibration source is placed under the patient, between the patient and the bed to induce shear waves in the liver. Ultrasound imaging through the patient ribs is used to track the displacements of these waves. Through tracking of the displacements, the shear wave velocity and tissue stiffness can be calculated. The use of volumetric multi-frequency imaging increases the amount of liver scanned

Also known as: MRE, MRI PDFF, Fibroscan

Open-label

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 19-75 years old
• Healthy volunteers or Patients with evidence of NAFLD such as one of the following:
• Previous liver biopsy consistent with NAFLD OR
• Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria:
• Abdominal ultrasound within 12 months
• MRI-PDFF (greater than 12%) within 12 month
• FibroScan CAP score \> 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (\>8kPa) within 12 months
• Able to understand the informed consent form, study procedures and willing to participate in study
• If female and of child bearing potential, must agree to practice a highly effective contraception method.

You may not qualify if:

• Active viral hepatitis
• a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible
• Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding)
• ALT or AST \> 5 x ULN on historical blood work within the past 3 months
• BMI greater than 40 kg/m2 (or using cutoff based on MRI)
• Other known causes of chronic liver disease
• Individuals with history of persistent ethanol abuse (alcohol consumption \> 20g etoh/day for women, \> 40 g etoh/day for men)
• Individuals with surgically removed gallbladder
• Pregnant or planning to become pregnant while enrolled in this study
• Other conditions which would exclude patients from entering an MRI

Sponsors & Collaborators

• Sonic Incytes: lead

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: December 24, 2020
• Study Start: October 21, 2020
• Primary Completion: November 1, 2022
• Study Completion: July 1, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

US (1)