MultiOrgan Multi-Parametric MRI Study

Type 2 Diabetes Clinical Trial

— MORIS  

Official title:

MultiOrgan Multi-Parametric MRI Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137705
• Other study ID #: CA0080
• Status: Recruiting
• Start date: November 4, 2019
• Est. completion date: November 25, 2023

Study information

• Verified date: April 2023
• Source: Perspectum
• Contact: Kim Chapman
• Phone: +44(0)1865655343
• Email: kim.chapman[@]perspectum.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• Multiparametric MRI
A standardised MRI protocol that provides a number of quantitative metrics on liver and other organs relevant to type 2 Diabetes - pancreas, kidneys, spleen, heart, lungs and aorta

Locations

Country	Name	City	State
United Kingdom	Beaver House	Oxford
United Kingdom	Gemini One	Oxford
United Kingdom	Oxford Centre for Magnetic Resonance	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Perspectum

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of the mean differences in body composition and multiple organ metrics between healthy participants and those with type 2 diabetes acquired with multiparametric MRI.	To determine the range of body composition and multi-organ metrics (liver, pancreas, aorta, heart, kidney, lungs and spleen) in healthy participants and in those with type 2 diabetes assessed using multiparametric MRI.	24 months
Primary	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.	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)	24 months
Secondary	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.	To determine the reproducibility of multiparametric MRI in the assessment of body composition and multiple organ structures (liver, pancreas, aorta, heart, kidney, lungs and spleen) obtained within separate MR scanning sessions.	24 months