GoutNCT00584311
MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs
A study testing MRI and Ultrasound in people with Gout, run by University of South Florida at 1 site in United States.
Trial summary
Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gout
- What is being tested?
- MRI and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Known history of gout
Who cannot join
- History of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic arthritis)
- History of another crystal induced arthritis (ex. pseudogout)
- Any contraindication to receiving an MRI (ex. pacemaker)
- Allergy to gadolinium contrast dye
- Inability to give informed consent
- Pregnant women
- Erosive changes on initial screening x-ray of index joint
- Serum Creatinine > 1.8 mg/dL at screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain radiographic changes that are seen in patients with chronic gout, far less is known about the changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and ultrasound (US). Further, there is very little data on the MRI and US appearance of asymptomatic joints in patients with hyperuricemia and symptomatic gout.
There is vast emerging data to suggest that MRI and US are much more sensitive than plain radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these imaging devices have revolutionized the treatment of RA, for the earlier detection of the skeletal changes of RA often mandates more aggressive therapy. These same changes would often be missed by plain radiographs.
Read more
It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical of gout much sooner than would plain radiography. We also hypothesize that these same imaging techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic joints of patients with symptomatic gout in other joints. As was the case with RA, the expected results of this study would mandate more aggressive therapy of both gout and hyperuricemia.
Our primary aim of this proposal would be accomplished by studying patients with known gout and normal plain radiographs. Each patient would have their most frequently involved joint (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or tophi with cortical damage). Any signs that may portend future joint destruction such as synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be documented. In order to demonstrate the effects of hyperuricemic silent deposition, an asymptomatic joint from these same patients will be studied using these same imaging techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue edema, or joint effusions will be recorded. By demonstrating destructive, or potentially destructive, skeletal changes in the index joint or asymptomatic joint of a significant number of patients, we will show that patients who are left untreated on the basis of normal plain radiographs are likely to already have skeletal damage.
- Conditions
- Gout
- Being tested
- MRI and Ultrasound
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and UltrasoundOther
MRI and US of the joint
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients (with no structural damage on the plain x-ray) will receive a MRI and Ultrasound (US) of their most involved joint and an asymptomatic joint. Receives: Other: MRI and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is presence or absence of skeletal damage (on either MRI or US). The data will then be analyzed in the same fashion but by MRI and US independently.
Measured: 2 weeks
Secondary outcomes (1)
The presence of erosions, tophi with cortical erosions, tophi without cortical erosions, bone marrow edema/reactive changes, soft tissue edema/swelling, synovial pannus, and joint effusions
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Investigators
- John D. Carter, M.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584311
- Sponsor's protocol ID
- 6123-G62368
- Other IDs
- 6123-G62368
- Status last verified
- Jun 2008
- First submitted
- 20 Dec 2007
- Last updated
- 9 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs
- ClinicalTrials.gov ID
- NCT00584311
- Acronym / sponsor ID
- 6123-G62368
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Jan 2008 (estimated)
- 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.
Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain radiographic changes that are seen in patients with chronic gout, far less is known about the changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and ultrasound (US). Further, there is very little data on the MRI and US appearance of asymptomatic joints in patients with hyperuricemia and symptomatic gout.
There is vast emerging data to suggest that MRI and US are much more sensitive than plain radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these imaging devices have revolutionized the treatment of RA, for the earlier detection of the skeletal changes of RA often mandates more aggressive therapy. These same changes would often be missed by plain radiographs.
It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical of gout much sooner than would plain radiography. We also hypothesize that these same imaging techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic joints of patients with symptomatic gout in other joints. As was the case with RA, the expected results of this study would mandate more aggressive therapy of both gout and hyperuricemia.
Our primary aim of this proposal would be accomplished by studying patients with known gout and normal plain radiographs. Each patient would have their most frequently involved joint (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or tophi with cortical damage). Any signs that may portend future joint destruction such as synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be documented. In order to demonstrate the effects of hyperuricemic silent deposition, an asymptomatic joint from these same patients will be studied using these same imaging techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue edema, or joint effusions will be recorded. By demonstrating destructive, or potentially destructive, skeletal changes in the index joint or asymptomatic joint of a significant number of patients, we will show that patients who are left untreated on the basis of normal plain radiographs are likely to already have skeletal damage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: MRI and UltrasoundAll patients (with no structural damage on the plain x-ray) will receive a MRI and Ultrasound (US) of their most involved joint and an asymptomatic joint. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Known history of gout
Key exclusion criteria (8 listed)
- History of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic arthritis)
- History of another crystal induced arthritis (ex. pseudogout)
- Any contraindication to receiving an MRI (ex. pacemaker)
- Allergy to gadolinium contrast dye
- Inability to give informed consent
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 |
|---|---|---|
| MRI and UltrasoundMRI and US of the joint | Other | 1 |
Primary outcome
The primary endpoint is presence or absence of skeletal damage (on either MRI or US). The data will then be analyzed in the same fashion but by MRI and US independently.
Time frame: 2 weeks
1 secondary outcome
The presence of erosions, tophi with cortical erosions, tophi without cortical erosions, bone marrow edema/reactive changes, soft tissue edema/swelling, synovial pannus, and joint effusions
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
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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.
John D. Carter, M.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Ultrasound in people with Gout, run by University of South Florida at 1 site in United States.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jun 2008. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is presence or absence of skeletal damage (on either MRI or US). The data will then be analyzed in the same fashion but by MRI and US independently. (time frame: 2 weeks). 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 9 Jun 2008.