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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336800
• Other study ID #: EC-248
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2022
• Source: Perspectum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Partners Imaging Centers	Sarasota	Florida

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 diabetic volunteers by inviting them to get a LiverMultiScanand collecting their contact information to seek interest in participating in future studies.		12 months
Secondary	To use multi-parametric MRI (LiverMultiScan) of the liver to assess liver health		12 months