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NCT04336618 Clinical Trial

Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

Non-Alcoholic Fatty Liver Disease Clinical Trial

— DFWRegistry  

Official title:
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04336618
Other study ID # EC-236
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 3, 2020
Est. completion date September 27, 2022

Study information
Verified date December 2023
Source Perspectum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date September 27, 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female volunteers aged 18 years and over• - Participant willing and able to give informed consent for participation in the registry. Exclusion Criteria: - 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Liver MultiScan
The LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics

Locations
Country Name City State
United States Perspectum Inc. Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Perspectum

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary To use multi-parametric MRI (LMS) of the liver to assess the volunteer's liver health 12 months
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