Non-Alcoholic Fatty Liver DiseaseNCT04341246
Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH)
An observational study of Non-Alcoholic Fatty Liver Disease, run by Perspectum at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate to provide evidence to establish tightly defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or PDFF. The study will be divided into 2 sub groups comprising of cases and controls. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- LiverMultiscan
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 12 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, deemed to be suitable for inclusion into a NASH clinical trial based on their clinical risk factors, and who have been referred for a standard of care diagnostic liver biopsy on suspicion of NASH
Who may be able to join
- Male and female subjects aged between 18-75 years
- Ability to understand and sign a written informed consent form (ICF)
- Patients who have undergone a liver biopsy within the last 6 weeks because of clinical suspicion on NAFL-D
Who cannot join
- Prior or planned liver transplantation
- Patients who have undergone a laparoscopic or wedge liver biopsy, or biopsy taken from the left lobe
- Participation in an investigational new drug (IND) trial in the 30 days before enrolment (except those patients who were not administered the IND)
- Other known causes of chronic liver disease based on clinical criteria at the study site, such as the following:
- Alcoholic liver disease
- Primary biliary cirrhosis
Show all 23Show fewer
- Primary sclerosing cholangitis
- Autoimmune hepatitis
- Wilson's disease, hemochromatosis, iron overload
- Alpha-1-antitrypsin (A1AT) deficiency
- Hepatitis C Virus, Hepatitis B Virus
- History or diagnosis of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Clinically relevant (more than 3 drinks per day on average for men and 2 for women) alcohol abuse within 12 months of liver biopsy and/or any recreational drugs
- Any contradiction or significant limitation to Magnetic Resonance imaging (MRI) scanning including but not limited to the following:
- Claustrophobia preventing Magnetic Resonance imaging (requires 15-30 minutes in scanner)
- Pacemaker or another implanted electronic device
- Metal in body (such as aneurysm clip) that might produce artefact on abdominal MRI or might be adversely impacted by a high magnetic field
- Inability to lie flat, remain till, or briefly hold breath as necessary during MR imaging
- Medical condition likely to produce significant hypervolemia like congestive heart failure
- Severe obesity complicating positioning within MR scanner
- Concomitant medical illnesses per investigators discretion that would hamper patient's completion of the study or otherwise affect the collected data (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer)
- Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study
- Failure to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH): A Case-control Study
The primary objective of this study is to evaluate to provide evidence to establish tightly defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or PDFF. The study will be divided into 2 sub groups comprising of cases and controls.
Read the detailed description
This is a prospective, case-control, study designed to measure the mean difference in cT1 and PDFF in patients who have undergone liver biopsy and have confirmed NASH and fibrosis or 'cases' (N=40) and N=20 patients with neither significant NASH nor significant fibrosis 'controls'.
Confirmed cases will be patients who have met the criteria for active NASH with fibrosis according to the NAS CRN scoring system (NAS≥4 \& F2-3), 'controls' will be those who did not meet NASH diagnostic criteria and have evidence of fibrosis of ≤2.
In addition, in order to investigate the variability of the biomarker investigators will assess the 'measurement' error in all participants by performing a repeat 'second' scan in the same scanning session, and , in cases only, 'biological' variability by performing a repeat scan in controls 2-4 weeks later.
Suitable patients based on trial inclusion criteria will be identified by the study PI and clinical collaborator and invited to receive one or two MRI scans from which cT1 and PDFF will be derived using Perspectum's LiverMultiScan software. Baseline scan will ideally be performed between 3 days (to allow for recovery from the procedure and time for biopsy results to become available) and 6 weeks following biopsy, to minimize the likelihood that the patient is in a significantly different pathophysiologic state on the baseline scan day than on the biopsy day.
In order to ensure that the investigators capture information on normal variability and not related to intervention they will also capture and record basic information at both measurement timepoints (e.g. body weight, waist circumference, details of lifestyle interventions).
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- LiverMultiscan
- Keywords
- NASH, Livermultiscan, fatty liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverMultiscanDevice
Also called LMS
The Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases are defined as those patients who have undergone liver biopsy and have confirmed NASH and fibrosis Receives: Device: LiverMultiscan | |
| Controls | Controls are patients have undergone a liver biopsy with neither significant NASH nor significant fibrosis Receives: Device: LiverMultiscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that a binary decision algorithm applied to cT1 can significantly identify patients whose liver biopsy results would qualify them for randomization in a clinical trial testing an investigational treatment for NASH
Mean cT1 (and PDFF) values for those with NAS≥4\&F2-3 (cases) and those with NAS<4 or F<2 (controls)
Measured: 6 weeks
Secondary outcomes (2)
To determine the measurement test-retest repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability within a single scanning session
Difference between two replicates (Scan A and Scan B in same session) under the same measurement conditions expressed as the repeatability coefficient
Measured: 1 day
To determine the biological repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability between scans acquired under the same conditions but 2-4 weeks apart
Difference between two scans (Scan 1 and Scan 2) under the same measurement conditions expressed as the repeatability coefficient
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start28 Jan 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
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 DiseaseStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen, Corey,, MD, MPH, MMSc, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341246
- Sponsor's protocol ID
- IIP-174
- Status last verified
- Jan 2024
- First submitted
- 7 Apr 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH): A Case-control Study
- ClinicalTrials.gov ID
- NCT04341246
- Acronym / sponsor ID
- IIP-174
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NASH, Livermultiscan, fatty liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 10 Apr 2020 (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 primary objective of this study is to evaluate to provide evidence to establish tightly defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or PDFF. The study will be divided into 2 sub groups comprising of cases and controls.
Detailed description
This is a prospective, case-control, study designed to measure the mean difference in cT1 and PDFF in patients who have undergone liver biopsy and have confirmed NASH and fibrosis or 'cases' (N=40) and N=20 patients with neither significant NASH nor significant fibrosis 'controls'.
Confirmed cases will be patients who have met the criteria for active NASH with fibrosis according to the NAS CRN scoring system (NAS≥4 \& F2-3), 'controls' will be those who did not meet NASH diagnostic criteria and have evidence of fibrosis of ≤2.
In addition, in order to investigate the variability of the biomarker investigators will assess the 'measurement' error in all participants by performing a repeat 'second' scan in the same scanning session, and , in cases only, 'biological' variability by performing a repeat scan in controls 2-4 weeks later.
Suitable patients based on trial inclusion criteria will be identified by the study PI and clinical collaborator and invited to receive one or two MRI scans from which cT1 and PDFF will be derived using Perspectum's LiverMultiScan software. Baseline scan will ideally be performed between 3 days (to allow for recovery from the procedure and time for biopsy results to become available) and 6 weeks following biopsy, to minimize the likelihood that the patient is in a significantly different pathophysiologic state on the baseline scan day than on the biopsy day.
In order to ensure that the investigators capture information on normal variability and not related to intervention they will also capture and record basic information at both measurement timepoints (e.g. body weight, waist circumference, details of lifestyle interventions).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Device: LiverMultiscanCases are defined as those patients who have undergone liver biopsy and have confirmed NASH and fibrosis |
| Controls | – | Device: LiverMultiscanControls are patients have undergone a liver biopsy with neither significant NASH nor significant fibrosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, deemed to be suitable for inclusion into a NASH clinical trial based on their clinical risk factors, and who have been referred for a standard of care diagnostic liver biopsy on suspicion of NASH
Key inclusion criteria (3 listed)
- Male and female subjects aged between 18-75 years
- Ability to understand and sign a written informed consent form (ICF)
- Patients who have undergone a liver biopsy within the last 6 weeks because of clinical suspicion on NAFL-D
Key exclusion criteria (23 listed)
- Prior or planned liver transplantation
- Patients who have undergone a laparoscopic or wedge liver biopsy, or biopsy taken from the left lobe
- Participation in an investigational new drug (IND) trial in the 30 days before enrolment (except those patients who were not administered the IND)
- Other known causes of chronic liver disease based on clinical criteria at the study site, such as the following:
- History or diagnosis of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
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 |
|---|---|---|
| LiverMultiscanAlso: LMSThe Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation | Device | Cases, Controls |
Primary outcome
To demonstrate that a binary decision algorithm applied to cT1 can significantly identify patients whose liver biopsy results would qualify them for randomization in a clinical trial testing an investigational treatment for NASH
Time frame: 6 weeks
Mean cT1 (and PDFF) values for those with NAS≥4\&F2-3 (cases) and those with NAS<4 or F<2 (controls)
2 secondary outcomes
To determine the measurement test-retest repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability within a single scanning session
Time frame: 1 day
To determine the biological repeatability of cT1 and PDFF in the target patient population by examining the test-retest variability between scans acquired under the same conditions but 2-4 weeks apart
Time frame: 2-4 weeks
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 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Kathleen, Corey,, MD, MPH, MMSc principal investigator
MGH
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 Non-Alcoholic Fatty Liver Disease, run by Perspectum at 1 site 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 3 inclusion and 23 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 3 Jan 2024. 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 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?
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?
To demonstrate that a binary decision algorithm applied to cT1 can significantly identify patients whose liver biopsy results would qualify them for randomization in a clinical trial testing an investigational treatment for NASH (time frame: 6 weeks). 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 3 Jan 2024.