A Phase I Study of NS-079 in Healthy Participants
NCT07669571
Healthy Adult Participants
Adelaide, South Australia, Australia
View Trial DetailsNCT Number: NCT07664982
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
Measured using Perspectum's LiverMultiScan
Time frame: 24 months
Measured using Perspectum's LiverMultiScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Time frame: 24 months
Measured using Perspectum's CoverScan
Perspectum
Industry
Global Reference Ranges (GRR) for Magnetic Resonance Imaging of Intra-abdominal Organs in Healthy Adults From Different Ethnic Groups - Mexico
Acronym: GRR Mexico
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