Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03914482 |
| Other study ID # |
6186 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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 50 patients 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.
A healthy volunteer study was conducted to test the overall feasibility of the device in use
in humans. The median liver fat percentage was in the normal range, less than six percent,
which helped gauge the accuracy of using the device in detecting low levels of liver fat. In
addition, the operator was able to optimize the use of the device on human scanning. Of the
25 study subject datasets analyzed, only 4 subjects had above normal liver fat by MRI fat
fraction (normal is < 6% fat fraction). All 4 study subjects with >6% liver fat fraction,
fell into 'mild liver fat' grade that spans 6% - 26% fat fraction, with the maximum value of
22%.
Using all 25 study subject datasets the TAEUS investigational device measurement has an R^2
correlation value of 0.61 with MRI measurements of fat fraction. This is particularly
interesting as BMI and abdominal fat thickness were found to have R^2 correlation values with
MRI measures of liver fat of 0.19 and 0.31, respectively.
