Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03757832 |
| Other study ID # |
111117 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2018 |
| Est. completion date |
August 8, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is being done to test the FLIP device, a novel device developed and manufactured
by Endra Life Sciences, located in Ann Arbor, Michigan. The purpose of the device is to
measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.
This feasibility study will involve 25 healthy volunteers having their liver imaged by
traditional ultrasound and MRI methods as well as using the FLIP device. The data obtained by
the FLIP will be compared with the data obtained by ultrasound and MRI in order to determine
the effectiveness of the device. This is a preliminary study to see if the investigational
device could eventually be used to image the liver alongside traditional ultrasound for
discerning fat concentration.
Description:
It has been demonstrated that thermoacoustic imaging can be used to identify water and fat
concentrations [Bauer, 2012]. In addition, the group led by Dr. Kruger have demonstrated that
conventional computed tomography shows similar features to thermoacoustic imaging in small
animal studies [Kruger, 2003]. These concepts have led Endra Life Sciences to develop the
FLIP device with the purpose of imaging fat concentration in liver tissue with indications
for fatty liver disease. Non-alcoholic fatty liver disease (NAFLD) was first reported in 1980
by pathologists at the Mayo clinic in obese, or overweight, patients with no history of
alcohol abuse. This represented the first time that fatty livers were observed with no
history of alcohol abuse. Since that first report of NAFLD, increased rates of obesity and
general increased caloric intake has dramatically increased rates of fatty liver disease.
Estimates of NAFLD range from 25 - 40% of the adult population globally. NAFLD is a
multi-system disease. Fatty liver disease is highly correlated with obesity and alcohol
abuse, and is an important biomarker of insulin resistance and metabolic disease. Endra's
technology offers a non-invasive, cost effective point of care solution to monitoring liver
fat content that will be enormously helpful in surveilling patients with metabolic disease,
insulin resistance, and those at risk for later stage liver disease.
This study will provide additional information that will guide the further development of the
FLIP device with the end goal of commercializing the product. Fibroscan is a device that is
currently on the market that is also indicated for fatty liver disease. Fibroscan is a shear
wave elastography device that measures the stiffness of liver tissue by mechanically
deforming tissue (by utilizing a plunger that vibrates the surface of the skin) and measures
the resulting shear wave speed within the liver by ultrasound. The shear wave speed is
related to the mechanical stiffness of the tissue. Fibroscan aims to assess the progression
of infiltration of collagen into normal liver tissue that results in scarring, characteristic
of fibrotic liver disease. Liver fibrosis progresses from fatty liver disease, not all fatty
liver disease patients develop fibrotic liver disease.
The Fibroscan device has an optional software module that attempts to quantify the
attenuation of the shear wave as it travels away from the plane of deformation. Fibroscan
refers to this measurement as CAP (Calculated Attenuation Parameter). The attenuation of the
shear wave is thought to be related to the degree of liver steatosis (fat content). To date,
the technique has demonstrated poor sensitivity, and is poorly correlated with quantitative
MRI measures of liver fat. Furthermore, CAP measurements in obese patients are difficult to
obtain and unreliable . Endra's technology aims to provide much more sensitive measurements
of liver fat content at the point of care. The Endra device has the potential to quantify fat
content as low as 5% (by volume). The system is interoperable with ultrasound and leverages
B-mode ultrasound imaging to guide measurement location. Compared to Fibroscan's CAP, Endra's
fatty liver measures are expected to be much more sensitive and reproducible based on
anatomical guidance by ultrasound imaging.
