Clinical trial NCT04336800: Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
Official title: Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Keywords: NASH
Fatty Liver
Livermultiscan
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2020-04-07
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic volunteers who are willing to get an MRI scan for the assessment of their liver

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.

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.

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).

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: To use multi-parametric MRI (LiverMultiScan) of the liver to assess liver health
timeFrame: 12 months
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Partners Imaging Centers
state: Florida
Study officials:
References: