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The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Fibrosis Liver Steatosis | Device: Liver Incyte | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| 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 : | April 2021 |
| Estimated Study Completion Date : | April 2021 |
| 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
|
- 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.
- 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.
- 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.
- 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.
| Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
| Contact: Caitlin Schneider, PhD | 6047287417 | caitlin@sonicincytes.com | |
| Contact: George Aliphtiras | 16047274145 | george@sonicincytes.com |
| 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 | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 3, 2019 | ||||||||
| First Posted Date ICMJE | May 21, 2019 | ||||||||
| Last Update Posted Date | March 17, 2021 | ||||||||
| Actual Study Start Date ICMJE | February 1, 2019 | ||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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.
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
|
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis | ||||||||
| Official Title ICMJE | The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis | ||||||||
| 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. | ||||||||
| 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Device: Liver Incyte
Ultrasound elasticity imaging
|
||||||||
| Study Arms ICMJE | 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.
Intervention: Device: Liver Incyte
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 2021 | ||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03957070 | ||||||||
| Other Study ID Numbers ICMJE | SI-CLIN-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sonic Incytes | ||||||||
| Study Sponsor ICMJE | Sonic Incytes | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Sonic Incytes | ||||||||
| Verification Date | July 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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