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

• ClinicalTrials.gov Identifier: NCT04336800
• Recruitment Status: Completed
• First Posted: April 7, 2020
• Last Update Posted: July 25, 2022
• Sponsor: Perspectum
• Information provided by (Responsible Party): Perspectum

Study Description

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.

Condition or disease	Intervention/treatment
Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2	Device: LiverMultiscan

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 Design

• Study Type: Observational
• Actual Enrollment: 74 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
• Actual Study Start Date: April 1, 2020
• Actual Primary Completion Date: January 1, 2022
• Actual Study Completion Date: January 1, 2022

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. To use multi-parametric MRI (LiverMultiScan) of the liver to assess liver health [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Diabetic volunteers who are willing to get an MRI scan for the assessment of their liver

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).

Contacts and Locations

Locations

United States, Florida

Partners Imaging Centers

Sarasota, Florida, United States, 34239

Sponsors and Collaborators

Perspectum

More Information

• Responsible Party: Perspectum
• ClinicalTrials.gov Identifier: NCT04336800
• Other Study ID Numbers: EC-248
• First Posted: April 7, 2020
• Last Update Posted: July 25, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Perspectum:

NASH; Fatty Liver; Livermultiscan

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases