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Fatty Liver Imaging Project ( FLIP ) Patient Pilot Study (FLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03914482
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : March 13, 2020
Endra Life Sciences
Information provided by (Responsible Party):
Aaron Fenster, Western University, Canada

Brief 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.

Condition or disease Intervention/treatment Phase
Fatty Liver Device: MRI Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study to Estimate Fat Concentration of Liver in Adults Through RF Imaging
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients at risk of FLD
Patients who choose to participate in the study that meet the inclusion criteria
Device: MRI
The device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality
Other Name: Liver Imaging

Primary Outcome Measures :
  1. Fat concentration estimate [ Time Frame: Up to 1 month following data collection ]
    The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients which have had at least 1 appointment with a clinician for liver function, diabetes, or obesity in the past year.
  • Must be over the age of 18.
  • Mild (6-26%), moderate (26-37%), or high (>37%) level of fat in the liver that is estimated by ultrasound imaging.
  • Must be proficient in English (reading/writing).

Exclusion Criteria:

  • Any metal or electronic implants including but not limited to pacemakers, metal clips, hips.
  • Pregnancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT03914482

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Contact: Aaron Fenster 5199315777

Sponsors and Collaborators
Aaron Fenster
Endra Life Sciences
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Responsible Party: Aaron Fenster, Scientist, Western University, Canada Identifier: NCT03914482    
Other Study ID Numbers: 6186
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases