HyperuricemiaTIGERNCT05434858
Imagery as Biomarker of Gout
A study testing Dual-energy CT (DECT) and ultrasound in people with Hyperuricemia, run by Lille Catholic University at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Dual-energy CT (DECT) and ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2022to 9 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to 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.
Read the detailed description
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.
- Conditions
- Hyperuricemia
- Being tested
- Dual-energy CT (DECT) and ultrasound
- Keywords
- Dual-energy computed tomography, hyperuricemia, gout, monosodium urate crystals
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy CT (DECT) and ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) | Experimental | Patients at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) will be included.
The participants included will be followed for a period of 60 months, with an initial visit, a final visit as well as an additional visit in case of suspicion of gout.
The presence of symptoms suggestive of gout will be evaluated during regular contact with the participants: a telephone call every 6 months as well as a postal or electronic mail every 3 months. Participants will be asked to contact the investigator if new symptoms or relevant medical events occur.
Blood (32.5 ml maximum) and urine (4 ml) samples will be taken from participants who have given their specific consent for a biological collection with a particular genetic aim. Receives: Other: Dual-energy CT (DECT) and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odd ratios and its 95% confidence interval for the development of gout
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
Measured: 60 months
Secondary outcomes (3)
Time until development of gout symptoms
Time from initial visit to onset of symptomatic gout
Measured: 60 months
Odd Ratio and its 95% confidence interval for gout development according to MSU volume
Measured: 60 months
Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start9 Sep 2022
- Primary completion31 Aug 2024
- Study completion9 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland University
- Responsible party
- Sponsor
- Investigators
- Tristan Pascart, MD, PhD, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434858
- Sponsor's protocol ID
- RC-P0097
- Acronym
- TIGER
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery as Biomarker of Imminent Transition From Asymptomatic Hyper Uricemia to Gout
- ClinicalTrials.gov ID
- NCT05434858
- Acronym / sponsor ID
- TIGER / RC-P0097
- Conditions
- Hyperuricemia
- Keywords
- Dual-energy computed tomography, hyperuricemia, gout, monosodium urate crystals
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Auckland University
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 9 Sep 2029 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) | Experimental | Other: Dual-energy CT (DECT) and ultrasoundPatients at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) will be included. The participants included will be followed for a period of 60 months, with an initial visit, a final visit as well as an additional visit in case of suspicion of gout. The presence of symptoms suggestive of gout will be evaluated during regular contact with the participants: a telephone call every 6 months as well as a postal or electronic mail every 3 months. Participants will be asked to contact the investigator if new symptoms or relevant medical events occur. Blood (32.5 ml maximum) and urine (4 ml) samples will be taken from participants who have given their specific consent for a biological collection with a particular genetic aim. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy CT (DECT) and ultrasoundDECT 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. | Other | Patient at high risk for gout due to elevated serum urate concentrations (≥ 8 mg/dL) |
Primary outcome
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
3 secondary outcomes
Time until development of gout symptoms
Time frame: 60 months
Odd Ratio and its 95% confidence interval for gout development according to MSU volume
Time frame: 60 months
Odd Ratio and its 95% confidence interval for comorbidities development according to MSU volume
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hyperuricemia
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Pascart, MD, PhD principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-energy CT (DECT) and ultrasound in people with Hyperuricemia, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odd ratios and its 95% confidence interval for the development of gout (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.