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

July 22, 2022 updated by: Perspectum
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Partners Imaging Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To use multi-parametric MRI (LiverMultiScan) of the liver to assess liver health
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perspectum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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