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OpenTrials
Active, Not Recruiting

NCT Number: NCT05434858

Imagery as Biomarker of Gout

The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

Cross-sectional studies have shown that 17% to 86% of people with apparently asymptomatic hyperuricemia have ultrasound evidence of monosodium urate (MSU) crystal deposition. These observations suggest that this deposition constitutes the first stage of the clinical gout syndrome, which has led to a revised model of disease progression and staging. However, no longitudinal studies have been undertaken to determine whether such findings are needed for the development of gout, or to investigate pathological mechanisms responsible for the transition from asymptomatic crystalline deposit to gout. Only a prospective cohort study of people at risk who are carefully and regularly followed can answer such questions.

Dual-energy computed tomography (DECT) and ultrasound are the two imaging techniques that allow the visualization and quantification of MSU crystals. Ultrasound is the most widely used technique; it allows the identification of the deposit of crystals of on the surface of the cartilage (double contour sign) and of the tophi. The DECT can detect the deposition of MSU crystals in soft tissues as long as the amount of crystals exceeds the spatial resolution of the machine (about 250 μm).

The international collaborative study TIGER (Transitions in gout research study) aims to address the question of the predictive value of the deposition of MSU crystals "silent" in the development of gout, through an international cohort (7 countries) including 907 asymptomatic hyperuricaemic individuals. These individuals will have initial ultrasounds to investigate the presence of MSU crystal deposits and a 5-year follow-up. Given the aforementioned ultrasound reproducibility issues, DECT analyzes will be added to the baseline assessment of TIGER participants to provide exploratory data on DECT as a potential biomarker for the impending development of gout.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Serum urate level ≥ 80 mg/L on inclusion,
  • No current or previous clinical symptoms of gout (including clinically apparent flares or tophus),
  • Between 18 and 80 years old,
  • Able to give informed consent.

Exclusion criteria

  • GFR (glomerular filtration rate) <30 ml / min / 1.73 m² or dialysis,
  • Serious illness with a poor prognosis of less than 5 years,
  • Autoimmune inflammatory arthritis,
  • Change of geographical area within 5 years,
  • Previous analysis of synovial fluid showing crystals of MSU,
  • Presence of subcutaneous tophi,
  • Taking a hypouricaemic treatment (allopurinol, probenecid, benzbromarone, febuxostat, lesinurad), canakinumab, anakinra or colchicine,
  • Uricemia observed only after an acute decompensation of comorbidity
  • Pregnant or breastfeeding women

Treatment and study plan

Dual-energy CT (DECT) and ultrasound

Other

DECT and ultrasound will be performed to clarify the pathological mechanisms responsible for the transition from asymptomatic crystalline deposition to gout, and the mechanisms involved in the transition from hyperuricemia to de novo crystalline deposition.

Primary outcomes

  1. Odd ratios and its 95% confidence interval for the development of gout

    Time frame: 60 months

    Development of symptomatic gout will be determined according to ACR/EULAR 2015 criteria at any time during the follow-up period. This scale is based on clinical, laboratory and imaging parameters. More than 8 points is considered as Gout. 0 is considered as absence of gout

Secondary outcomes

  1. Time until development of gout symptoms

    Time frame: 60 months

    Time from initial visit to onset of symptomatic gout

  2. Odd Ratio and its 95% confidence interval for gout development according to MSU volume

    Time frame: 60 months

  3. Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Auckland University

Registry information

Official study title

Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout

Acronym: TIGER

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Jun 28, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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