Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

• Registration Number: NCT04336800
• Lead Sponsor: Perspectum

Brief Summary

To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.

Detailed Description

Perspectum's LiverMultiScan is a quantitative multiparametric MRI method, FDA-cleared and CE-marked, that is used to detect and stage early liver disease.It is already widely used internally in both research and within the clinical setting. LiverMultiScan has been adopted as the only liver scan in whole-population long term studies. The LiverMultiScan is more cost efficient, short in duration(\<15mins), non-invasive and safe(no IV or oral contrast required, no ionizing radiation and no venipuncture).

This is a registry where there will be no intervention to the standard of care. Registry volunteers will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the investigators will collect contact information of the volunteers including their email address, phone number and home 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 volunteer's personal information shall never be shared with these third parties. Additionally, the contact information of the volunteers' medical providers shall also be collected so that the LiverMultiScan reports can be delivered to them.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Male or female diabetic volunteers aged 18 years and over who are willing and able to give informed consent for participation in the registry.

Exclusion Criteria

• The volunteer 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To build a registry of diabetic volunteers by inviting them to get a LiverMultiScanand collecting their contact information to seek interest in participating in future studies.	12 months

Secondary Outcome Measures

Name	Time	Method
To use multi-parametric MRI (LiverMultiScan) of the liver to assess liver health	12 months

Trial Locations

Locations (1)

Partners Imaging Centers; 🇺🇸 Sarasota, Florida, United States