MultiOrgan Multi-Parametric MRI Study

Perspectum3 sites in 1 country43 target enrollmentNovember 4, 2019

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Perspectum
Enrollment: 43
Locations: 3
Primary Endpoint: Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics.
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.

Registry

clinicaltrials.gov

Start Date

November 4, 2019

End Date

November 25, 2023

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Perspectum

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Any person over 18 years of age.
•Participant is willing and able to give informed consent for participation in the investigation.
•EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer

Exclusion Criteria

•The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
•Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation

Outcomes

Primary Outcomes

Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics.

Time Frame: 24 months

To determine the repeatability of multiparametric MRI in the assessment of body composition and multiple organ structures obtained within a single MR scanning session (liver, pancreas, aorta, heart, kidney, lungs and spleen)

Secondary Outcomes

Assessment of the reproducibility (precision under different measurement conditions: same participants scanned on separate MRI scanners at both 1.5T and 3T) of multiparametric MRI for the assessment of body composition and multiple organ metrics.(24 months)