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The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

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ClinicalTrials.gov Identifier: NCT03957070
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sonic Incytes

Brief Summary:
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Liver Steatosis Device: Liver Incyte Not Applicable

Detailed Description:

This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit.

The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure.

The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Experimental: Liver Incyte
Patients with successfully treated HCV, or NASH Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.
Device: Liver Incyte
Ultrasound elasticity imaging




Primary Outcome Measures :
  1. Discrimination of healthy from patients with liver fibrosis [ Time Frame: 6 months ]

    The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

    An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated.



Secondary Outcome Measures :
  1. Safety of the device as measured by rate of adverse events [ Time Frame: 6 months ]

    The safety and tolerability of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis

    Rate of adverse events when using the investigational device will be reported.



Other Outcome Measures:
  1. Agreement between Liver Incytes and MRI elastography measurements [ Time Frame: 6 months ]
    Elasticity measurements from Liver Incyte and MRE will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. As in the analysis for the Primary Objective, an ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HVC/NASH) will be calculated.

  2. Correlation between Liver Incytes and MRI elastography measurements [ Time Frame: 6 months ]
    Steatosis measurements from Liver Incyte, Fibroscan (CAP), and MRI (PDFF) will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. An ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HCV/NASH) will be calculated.



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any sex, ages 19-75 years inclusively
  • Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12).
  • Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals.
  • Able to understand the informed consent form, study procedures and willing to participate in study

Exclusion Criteria:

  • Unable to achieve SVR12 with previous antiviral treatment for HCV
  • Multiple (>1) liver disease diagnoses within the past 12 months
  • Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years
  • Documented or known ascites
  • Documented or known portal hypertension
  • BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants)
  • If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  • Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 10 grams of alcohol])
  • Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators.
  • Individuals with surgically removed gallbladder (for optional MRE procedure only)

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): NCT03957070


Contacts
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Contact: Caitlin Schneider, PhD 6047287417 caitlin@sonicincytes.com
Contact: George Aliphtiras 16047274145 george@sonicincytes.com

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Sheila Wilson    617-632-1086    sawilson@bidmc.harvard.edu   
Canada, British Columbia
LAIR Recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
Contact: Fran Cornell    1 604 876 5122 ext 2240    fcornell@laircentre.com   
Sponsors and Collaborators
Sonic Incytes

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Responsible Party: Sonic Incytes
ClinicalTrials.gov Identifier: NCT03957070     History of Changes
Other Study ID Numbers: SI-CLIN-01
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sonic Incytes:
liver
ultrasound elastography

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Fatty Liver
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics