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 : September 18, 2019
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
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
|Contact: Caitlin Schneider, PhDfirstname.lastname@example.org|
|Contact: George Aliphtirasemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sheila Wilson 617-632-1086 firstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1H2|
|Contact: Fran Cornell 1 604 876 5122 ext 2240 email@example.com|