US company evaluates Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
The company Sonic Incytes is conducting the clinical trial The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF.
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.
The Liver Incytes system allows for full visualization of the liver with the low cost and portability of ultrasound. It is an adjustable multi-frequency technique, which can show large areas of the organ as volumetric elasticity maps. The device uses the Shear Wave Absolute Vibro-Elastography (S-WAVE) method.
The primary objective of the study is to determine the relationship between the elasticity results from Liver Incytes and those of MR Elastography. In addition to stiffness measurements, the relationship between the Liver Incytes attenuation measurements and MR-PDFF will also be evaluated.
It is planned to include 100 participants.
Actual study start date is October 21, 2020. The researchers expect to complete the study by May 1, 2022.
Among the exclusion criteria are:
- Active viral hepatitis
- 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
- 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
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04682600) Boston, United States.
