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Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration (DEteCT)

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ClinicalTrials.gov Identifier: NCT03038386
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mihaela Gamala, Meander Medical Center

Brief Summary:

Rationale: Gout is a disease with growing incidence and complexity due to increased life expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy, demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is difficult to ascertain due to sampling error (no synovial fluid acquired because the needle was not exactly placed in the affected joint, or the location of the gout might have been extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g. infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This technique allows the visualization and quantification of MSU. Although imaging modalities such as DECT show promise in the classification of gout, the studies to date have been small and have primarily involved people with established disease.

A study with cross-sectional design in which patients for whom the clinical questions "does this patient have gout?" are referred for participation may contribute to assess the value of DECT scan in diagnosing acute arthritis caused by gout.

Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.

Study design: Prospective Study population: Patients with acute mono or oligo arthritis without prior diagnosis, the rheumatologist has an indication for diagnostic needle aspiration.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by blind aspiration or ultra sound guided aspiration depending on the judgement of the rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been established and is therefore not used in daily practice. In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy


Condition or disease Intervention/treatment Phase
Gout Other: Dual Energy CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration
Study Start Date : April 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout Nuclear Scans

Arm Intervention/treatment
Dual Energy CT
In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy
Other: Dual Energy CT
In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy




Primary Outcome Measures :
  1. The sensitivity and specificity (95% CI) of DECT scanning for the detection of MSU deposits [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. clinical and laboratory predicators of positive DECT scan in patients with acute mono or oligo arthritis [ Time Frame: 2 weeks ]
  2. number of participants, in whom the first aspirate demonstrated no MSU and/or no synovial fluid, with MSU demonstrated after ultrasound guided joint aspiration [ Time Frame: 2 weeks ]
  3. number of participants with positive DECT lesions, in whom the first aspirate(s) demonstrated no MSU and/or no synovial fluid with MSU demonstrated after ultrasound guided joint aspiration at the place of positive DECT lesion [ Time Frame: 2 weeks ]
  4. cost of the gout diagnostic strategies (blind joint aspiration, ultrasound guided joint aspiration, DECT) will be calculated [ Time Frame: 2 weeks ]
  5. Patient satisfaction: What does the patient experience as the most patient-friendly way of diagnosing gout: DECT scan, ultrasound-guided joint aspiration or blind aspiration? [ Time Frame: 2 weeks ]
    VAS DECT, blind joint aspiration, ultrasound guided joint aspiration

  6. correlation between cardiovascular risk and the urate volume on DECT [ Time Frame: 2 weeks ]
    correlation coefficient between cardiovascular risk (SCORE European and ACC/AHA) and the urate volume on DECT

  7. number of patients with clinical diagnosis gout 6 and 12 month after het DECT [ Time Frame: 6 and 12 month ]
  8. number of patients on urate lowering medication 6 and 12 month after the DECT [ Time Frame: 6 and 12 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Mono or oligo arthritis (2-3 swollen joints)
  • Indication for diagnostic aspiration of an inflamed joint in which gout is one of the possibilities

Exclusion Criteria:

  • Polyarthritis ( up to 4 swollen joint);
  • Chrystal proven gout in history
  • Patient is on uric acid lowering therapy (Allopurinol, Benzbromaron, Febuxostat)
  • Hip arthritis*
  • Metal or prosthesis of the inflamed joint
  • Highly suspicion of infectious arthritis
  • Pregnancy
  • Contra indication of joint aspiration (skin infection, hemophilia)
  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038386


Contacts
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Contact: Ruth Klaasen, MD, PhD 0031338505050 r.klaasen@meandermc.nl
Contact: Mihaela Gamala, MD 0031338505050 m.gamala@umcutrecht.nl

Locations
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Netherlands
Meander Medical Center Recruiting
Amersfoort, Utrecht, Netherlands
Contact: Ruth Klaasen, MD, PhD    0031338505050    r.klaasen@menadermc.nl   
Contact: Mihaela Gamala, MD       m.gamala@umcutrecht.nl   
Principal Investigator: Ruth Klaasen, MD, PhD         
Sub-Investigator: Mihaela Gamala, MD         
Sponsors and Collaborators
Meander Medical Center
Investigators
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Principal Investigator: Ruth Klaasen, MD, PhD Meander Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mihaela Gamala, MD, Meander Medical Center
ClinicalTrials.gov Identifier: NCT03038386     History of Changes
Other Study ID Numbers: NL54454.100.15
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided