Non-alcoholic Fatty Liver Disease (NAFLD)NCT05908006
Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by GI Alliance at 2 sites in United States.
Trial summary
The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to: Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Velacur
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2023to 31 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All sexes, 18-80 years old. Patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including both those with Non-Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH).
Who may be able to join
- Patients with evidence of NAFLD or other chronic liver disease such as one of the following:
- Biopsy proven chronic liver disease OR
- Evidence of hepatic steatosis or chronic liver disease on non-invasive assessment by one or more of the following criteria:
- Abdominal ultrasound within 12 months
- MRI-PDFF (greater than 12%) within 12 months
- FibroScan CAP score > 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (>8kPa) within 12 months
Who cannot join
- BMI greater than 40 kg/m2 (or unable to fit into MRI bore)
- Subject with current, significant alcohol consumption or history of significant alcohol consumption
- Subjects with evidence of decompensated liver disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GI Alliance-Flowood, MS
Flowood, Mississippi, 39232
Nolan Runnels, RN, BSN, 601-863-0395, Nolan.Runnels@gastrodocs.net
GI Alliance-Webster, TX
Webster, Texas, 77598
Tessa Kus, MPH, 281-699-1715, Tessa.Kus@GIAlliance.com
About this study
Official title: Comparison of Steatosis and Fibrosis Measurements From Velacur and MRE/MRI-PDFF in Patients With Chronic Liver Disease
The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to:
- Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging.
- Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging.
Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).
Read the detailed description
This will be a prospective, open label, validation study of the Velacur system in comparison to MRE and MRI-PDFF in patients with liver disease or suspected liver disease.
Approximately 100 subjects may be enrolled in this study. Participants should span all levels of fibrosis and steatosis.
The study is comprised of: Screening Period (up to 8 days) and Visit 1. There are no safety follow-up visits in this study.
The primary objective of the study is to compare the results of Velacur against MRE and MRI-PDFF results for liver stiffness and steatosis. As part of prior studies, using MRE as the gold standard, clinical cut-off for Velacur have been developed. The primary objective of this study is to validate these cut-offs to see if Velacur can correctly classify patients.
Secondary objectives include correlating the stiffness and attenuation results of Velacur with other clinical measures of fibrosis and steatosis such as Fib-4, and correlations with other clinical measurements collected through clinical care or clinical trials, such as Enhance Liver Fibrosis (ELF) test, FibroScan, MRI, or ultrasound based shear wave elastography (SWE) as they are available.
- Being tested
- Velacur
- Keywords
- NASH, NAFL
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelacurDevice
Also called MRE/MRI, Fibroscan
Imaging Procedures Comparison
| Study group | Role | What they receive |
|---|---|---|
| non-randomized, open-label study | All participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures. Receives: Device: Velacur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity measurements
Validate the use of Velacur and elastography cut offs with all types of chronic liver disease, against MRE results for fibrosis staging. The liver tissue elasticity is measured in kilopascals (kPa), using Velacur.
The Velacur elasticity measurements will be compared to those from Magnetic Resonance Elastography, which is measuring liver tissue elasticity in kilopascals (kPa).
Measured: 2024
Attenuation measurement
Validate the use of Velacur and attenuation cut offs with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Ultrasound attenuation is a quantitative measurement of ultrasound image parameters. Attenuation is measured by Velacur, and uses units of of decibels per meter (dB/m).
These numbers are compared to the fat percentage as measured by MRI proton density fat fraction, which is measured in percentage fat (%).
Measured: 2024
Secondary outcomes (2)
Serum markers such as Fib-4, APRI and NALFD Fibrosis score or ELF (enhanced liver fibrosis) score.
Comparison of Velacur stiffness and attenuation results with other clinical measures of fibrosis and steatosis, such as blood work, using readily available scores and attenuation results with other clinical measures of fibrosis and steatosis, such as blood work, using readily available scores.
Measured: 2024
The combined outputs of elasticity and attenuation from Velacur and FibroScan
Discriminatory ability of Velacur compared with other noninvasive markers, such as FibroScan
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jul 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GI Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Sonic Incytes
- Responsible party
- Sponsor
- Investigators
- Sri Naveen Surapaneni, MD, Principal investigator, GI AllianceReed B Hogan, III, MD, Principal investigator, GI Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908006
- Sponsor's protocol ID
- Velacur-2
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Steatosis and Fibrosis Measurements From Velacur and MRE/MRI-PDFF in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05908006
- Acronym / sponsor ID
- Velacur-2
- Keywords
- NASH, NAFL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GI AllianceUniversity, hospital or other
- Collaborators
- Sonic Incytes
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Jun 2023 (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.
The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to:
- Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging.
- Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging.
Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).
Detailed description
This will be a prospective, open label, validation study of the Velacur system in comparison to MRE and MRI-PDFF in patients with liver disease or suspected liver disease.
Approximately 100 subjects may be enrolled in this study. Participants should span all levels of fibrosis and steatosis.
The study is comprised of: Screening Period (up to 8 days) and Visit 1. There are no safety follow-up visits in this study.
The primary objective of the study is to compare the results of Velacur against MRE and MRI-PDFF results for liver stiffness and steatosis. As part of prior studies, using MRE as the gold standard, clinical cut-off for Velacur have been developed. The primary objective of this study is to validate these cut-offs to see if Velacur can correctly classify patients.
Secondary objectives include correlating the stiffness and attenuation results of Velacur with other clinical measures of fibrosis and steatosis such as Fib-4, and correlations with other clinical measurements collected through clinical care or clinical trials, such as Enhance Liver Fibrosis (ELF) test, FibroScan, MRI, or ultrasound based shear wave elastography (SWE) as they are available.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-randomized, open-label study | – | Device: VelacurAll participants will have the same Laboratory and Diagnostic Assessments and Imaging Procedures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sexes, 18-80 years old. Patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including both those with Non-Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH).
Key inclusion criteria (6 listed)
- Patients with evidence of NAFLD or other chronic liver disease such as one of the following:
- Biopsy proven chronic liver disease OR
- Evidence of hepatic steatosis or chronic liver disease on non-invasive assessment by one or more of the following criteria:
- Abdominal ultrasound within 12 months
- MRI-PDFF (greater than 12%) within 12 months
Key exclusion criteria (3 listed)
- BMI greater than 40 kg/m2 (or unable to fit into MRI bore)
- Subject with current, significant alcohol consumption or history of significant alcohol consumption
- Subjects with evidence of decompensated liver disease
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 |
|---|---|---|
| VelacurAlso: MRE/MRI, FibroscanImaging Procedures Comparison | Device | non-randomized, open-label study |
Primary outcome
Elasticity measurements
Time frame: 2024
Validate the use of Velacur and elastography cut offs with all types of chronic liver disease, against MRE results for fibrosis staging. The liver tissue elasticity is measured in kilopascals (kPa), using Velacur. The Velacur elasticity measurements will be compared to those from Magnetic Resonance Elastography, which is measuring liver tissue elasticity in kilopascals (kPa).
Attenuation measurement
Time frame: 2024
Validate the use of Velacur and attenuation cut offs with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Ultrasound attenuation is a quantitative measurement of ultrasound image parameters. Attenuation is measured by Velacur, and uses units of of decibels per meter (dB/m). These numbers are compared to the fat percentage as measured by MRI proton density fat fraction, which is measured in percentage fat (%).
2 secondary outcomes
Serum markers such as Fib-4, APRI and NALFD Fibrosis score or ELF (enhanced liver fibrosis) score.
Time frame: 2024
The combined outputs of elasticity and attenuation from Velacur and FibroScan
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Sri Naveen Surapaneni, MD principal investigator
GI Alliance
Reed B Hogan, III, MD principal investigator
GI Alliance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by GI Alliance at 2 sites in United States.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jo Ann Gilbert (972-637-8546, JoAnn.Gilbert@GIAlliance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity measurements (time frame: 2024). The study lists 2 primary outcomes in all. 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 18 Jun 2023.