Global Reference Ranges - Mexico (GRR Mexico)

Global Reference Ranges (GRR) for Magnetic Resonance Imaging of Intra-abdominal Organs in Healthy Adults From Different Ethnic Groups - Mexico

The investigators aim to undertake the Global Reference Range Study (GRR) to establish a set of healthy adult reference values for measures of fibroinflammation, fat and size/volumes for the liver, and other abdominal and thoracic organs to assess, compare, and if necessary, propose ethnicity specific reference ranges for these measurements.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants

Detailed Description

The increasing rates of global obesity have been substantial in the adult population. Obesity is associated with metabolic syndromes and poses a major risk factor for diabetes, cardiovascular disease (CVD), and premature mortality. There has been a recent change in the definition and diagnosis of (clinical) obesity which emphasises that to identify early and effective treatments to prevent adverse clinical outcomes, it is essential to evaluate the health across multiple organs in the body. The advancements in multiorgan imaging to evaluate organ health is key in guiding risk stratification, diagnosis of organ-specific abnormalities and the development of targeted treatment strategies, and in recent years the indications for magnetic resonance imaging (MRI) have significantly expanded. In chronic liver diseases, the investigators have previously shown that multiparametric MRI of the liver has prognostic capabilities, and in the detection of treatment response. The investigator's multiorgan MRI method is a non-contrast MRI acquisition that allows for the measurement of fibro-inflammation and fat in and around the abdominal and thoracic organs, as well as the characterisation of organ size and volume and, specific to the heart, cardiac function in a single MRI scan. This approach has revealed persistence of multiorgan abnormalities across a range of disease indications including with people living with type 2 diabetes and lasting effects following COVID-19 infection. Many of the approaches for organ quantification have been adopted into routine clinical practice, for example liver MRI has been included in clinical guidelines for the assessment of MASH. However, as for all imaging modalities, being able to distinguish between healthy and diseased organs is critical - which relies on the availability of robust healthy reference ranges. Current MRI reference values have been predominantly based on white population datasets, whilst very limited values from other ethnic populations exist. There are well-known ethnic variations in healthy cardiovascular phenotypes based on echocardiographic studies. Consequently, there is a need to establish the healthy reference ranges across a range of ethnicities stratified against biological sex and age to allow for global comparison of MRI measures.

• Study Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, aged 18 years and over.

Description

Inclusion Criteria:

• Male or female at least 18 years of age
• Self-reported healthy
• Willing and able to give informed consent for participation in the study
• Willing and able to undergo an MRI

Exclusion Criteria:

• History of cardiovascular disease as follows:

  • Myocardial infarction
  • Heart failure
  • Cardiomyopathy
  • Stroke
  • Hospital admission/discharge for unstable angina
  • Heart surgery
  • Unstable angina
  • Transient ischemic attack
• Presence of CVD risk factors such as hypertension, hyperlipidaemia, Type 2 diabetes, BMI > 30 kg/m2, smoker (current/ex-smoker)
• History of non-cardiac diseases related to the lungs, liver, kidneys, pancreas or spleen judged by the study investigator as therefore unsuitable to participate in the study
• The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MRI exclusion criteria including 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 study, or may influence the participant's ability to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference intervals for liver cT1	Measured using Perspectum's LiverMultiScan	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference intervals for liver PDFF, iron and volume	Measured using Perspectum's LiverMultiScan	24 months
Reference intervals for pancreas T1 and PDFF	Measured using Perspectum's CoverScan	24 months
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)	Measured using Perspectum's CoverScan	24 months
Reference intervals for measures of body composition	Measured using Perspectum's CoverScan	24 months
Reference intervals for cardiac volumes and function	Measured using Perspectum's CoverScan	24 months
Reference intervals for spleen T1 and volume	Measured using Perspectum's CoverScan	24 months
Reference intervals for lungs fractional change	Measured using Perspectum's CoverScan	24 months
Reference intervals for biliary tree and pancreatic duct metrics	Measured using Perspectum's CoverScan	24 months

Collaborators and Investigators

• Sponsor: Perspectum

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EC-554