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

NCT ID: NCT04336800

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-01-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

LiverMultiscan

The LiverMultiscan is a quick 15 min, contrast free scan that non-invasively provides three metrics of liver health namely liver fat, iron and fibro-inflammation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Perspectum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Partners Imaging Centers

Sarasota, Florida, United States

Countries

United States

Other Identifiers

EC-248

Identifier Type: -

Identifier Source: org_study_id