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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

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 groups in NCT00584311
Study groupRoleWhat they receive
1ExperimentalAll 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.

  1. 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)
  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.

  1. First posted2 Jan 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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)
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

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.

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