Non-Alcoholic Fatty Liver DiseaseDFWRegistryNCT04336618
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
An observational study of Non-Alcoholic Fatty Liver Disease, run by Perspectum at 1 site in United States.
Trial summary
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Liver MultiScan
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 27 Sep 2022
- 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: Adult volunteers willing to get an MRI scan for the assessment of their liver
Who may be able to join
- Male or female volunteers aged 18 years and over•
- Participant willing and able to give informed consent for participation in the registry.
Who cannot join
- The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
Trial locations and contacts
1 site in 1 country.
About this study
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.
Read the detailed description
This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.
Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.
A total of 100 participants will be enrolled over a period of 1 year.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Liver MultiScan
- 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.
Liver MultiScanDevice
The LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics
What is being measured
The primary outcome is the main question the study is designed to answer.
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies
Measured: 12 months
Secondary outcomes (1)
To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start3 Aug 2020
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336618
- Sponsor's protocol ID
- EC-236
- Acronym
- DFWRegistry
- Status last verified
- Dec 2023
- First submitted
- 3 Apr 2020
- Last updated
- 22 Dec 2023
- Results posted
- 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
- ClinicalTrials.gov ID
- NCT04336618
- Acronym / sponsor ID
- DFWRegistry / EC-236
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 7 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.
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.
Detailed description
This is a Registry where there will be no intervention to the standard of care.Participants will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the invesigators will collect contact information of participants including their email address, phone number and house address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies, the participants personal information shall never be shared with these third-parties. Additionally, the contact information of the participants medical providers shall be collected so that, if requested, their LMS reports can be used in their diagnostic pathway.
Imaging will be performed at two Touchstone Imaging locations, one in downtown Dallas and the other in Southlake.
A total of 100 participants will be enrolled over a period of 1 year.
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
- Adult volunteers willing to get an MRI scan for the assessment of their liver
Key inclusion criteria (2 listed)
- Male or female volunteers aged 18 years and over•
- Participant willing and able to give informed consent for participation in the registry.
Key exclusion criteria (1 listed)
- The participant may not enter the Registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
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 MultiScanThe LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics | Device | – |
Primary outcome
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies
Time frame: 12 months
1 secondary outcome
To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health
Time frame: 12 months
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 22 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 inclusion and 1 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 22 Dec 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 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 build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek their interest in participating in future studies (time frame: 12 months). 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 22 Dec 2023.