NCT07166471

Brief Summary

We 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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Sep 2027

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

September 3, 2025

Last Update Submit

November 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the reference values for liver fibroinflammation in healthy adults from different ethnic groups.

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers, aged 18 years and over.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ravi Pattanshetty

    Perspectum

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

December 31, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 5, 2025

Record last verified: 2025-11