Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration

NCT03038386 | Unknown DMC

• 1 other identifier: NL54454.100.15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity (95% CI) of DECT scanning for the detection of MSU deposits

  2 weeks

Secondary Outcomes (8)

• clinical and laboratory predicators of positive DECT scan in patients with acute mono or oligo arthritis

  2 weeks

• number of participants, in whom the first aspirate demonstrated no MSU and/or no synovial fluid, with MSU demonstrated after ultrasound guided joint aspiration

  2 weeks

• 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

  2 weeks

• cost of the gout diagnostic strategies (blind joint aspiration, ultrasound guided joint aspiration, DECT) will be calculated

  2 weeks

• 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?

  2 weeks

Study Arms (1)

Dual Energy CT

OTHER

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

Interventions

Dual Energy CT OTHER

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

Dual Energy CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meander Medical Center: lead

Study Sites (1)

Meander Medical Center

Amersfoort, Utrecht, Netherlands

RECRUITING

Related Publications (1)

• Gamala M, Jacobs JWG, Linn-Rasker SF, Nix M, Heggelman BGF, Pasker-de Jong PCM, van Laar JM, Klaasen R. The performance of dual-energy CT in the classification criteria of gout: a prospective study in subjects with unclassified arthritis. Rheumatology (Oxford). 2020 Apr 1;59(4):845-851. doi: 10.1093/rheumatology/kez391.

  PMID: 31504985 DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ruth Klaasen, MD, PhD

  Meander Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Klaasen, MD, PhD

CONTACT

0031338505050; r.klaasen@meandermc.nl

Mihaela Gamala, MD

CONTACT

0031338505050; m.gamala@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: January 31, 2017
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

NL (1)