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Global Reference Ranges - Mexico (GRR Mexico)
17 augustus 2026 bijgewerkt door: Perspectum
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
50
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Healthy volunteers, aged 18 years and over.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reference intervals for liver cT1
Tijdsspanne: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reference intervals for liver PDFF, iron and volume
Tijdsspanne: 24 months
|
Measured using Perspectum's LiverMultiScan
|
24 months
|
|
Reference intervals for pancreas T1 and PDFF
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for kidney cortical T1 and renal sinus fat volume (RSFV)
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for measures of body composition
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for cardiac volumes and function
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for spleen T1 and volume
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for lungs fractional change
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
|
Reference intervals for biliary tree and pancreatic duct metrics
Tijdsspanne: 24 months
|
Measured using Perspectum's CoverScan
|
24 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 augustus 2029
Studie voltooiing (Geschat)
1 augustus 2029
Studieregistratiedata
Eerst ingediend
12 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juni 2026
Eerst geplaatst (Werkelijk)
24 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- EC-554
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .