Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA DeviceFLIPNCT03757832
Fatty Liver Imaging Project
An observational study of Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device and Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI, run by Aaron Fenster at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device, Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI, Provide Insight Into the Sensitivity of Thermoacoustic Liver Fat Assessment With the Aim of Detecting Fat Content in Liver at 15% or Less, by Volume
- What is being tested?
- Liver Imaging
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2018to 8 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This feasibility study will recruit 25 healthy volunteers to undergo an ultrasound and thermoacoustic, and MRI examination of their liver while breathing normally, and during short breath-hold periods
Who may be able to join
- - Healthy volunteers which represent a range of genders, age, BMI and lifestyle.
- Must be over the age of 18.
- Must be proficient in English (reading/writing).
Who cannot join
- - Any metal or electronic implants including but not limited to pacemakers, metal clips, hips.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Estimate Fat Concentration of Liver in Adults Through RF Imaging
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.
Read the 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.
- Conditions
- Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device, Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI, Provide Insight Into the Sensitivity of Thermoacoustic Liver Fat Assessment With the Aim of Detecting Fat Content in Liver at 15% or Less, by Volume
- Being tested
- Liver Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver ImagingDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat concentration estimate
The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.
Measured: September 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start20 Sep 2018
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Fenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Fenster, Western University, Canada
- Investigators
- Aaron Fenster, PhD, Principal investigator, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757832
- Sponsor's protocol ID
- 111117
- Acronym
- FLIP
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2018
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Estimate Fat Concentration of Liver in Adults Through RF Imaging
- ClinicalTrials.gov ID
- NCT03757832
- Acronym / sponsor ID
- FLIP / 111117
- Conditions
- Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device, Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI, Provide Insight Into the Sensitivity of Thermoacoustic Liver Fat Assessment With the Aim of Detecting Fat Content in Liver at 15% or Less, by Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aaron FensterUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This feasibility study will recruit 25 healthy volunteers to undergo an ultrasound and thermoacoustic, and MRI examination of their liver while breathing normally, and during short breath-hold periods
Key inclusion criteria (3 listed)
- - Healthy volunteers which represent a range of genders, age, BMI and lifestyle.
- Must be over the age of 18.
- Must be proficient in English (reading/writing).
Key exclusion criteria (2 listed)
- - Any metal or electronic implants including but not limited to pacemakers, metal clips, hips.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver ImagingThe device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality. | Device | – |
Primary outcome
Fat concentration estimate
Time frame: September 2019
The purpose of the device is to measure the fat content of liver tissue to assist in the diagnosis of fatty liver disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Fenster, PhD principal investigator
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determine the Number of Anatomical Sites at Which Successful Thermoacoustic Fat Measurements Can be Made From Five Acquisitions Using the FLIP ITA Device and Determine the Correlation of Fat Measures Obtained by the FLIP Device and Those Obtained From Quantitative MRI, run by Aaron Fenster at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat concentration estimate (time frame: September 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.