Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration

NCT ID: NCT03038386

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Dual Energy CT

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meander Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mihaela Gamala

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth Klaasen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Meander Medical Center

Locations

Meander Medical Center

Amersfoort, Utrecht, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Ruth Klaasen, MD, PhD

Role: CONTACT

r.klaasen@meandermc.nl

0031338505050

Mihaela Gamala, MD

Role: CONTACT

m.gamala@umcutrecht.nl

0031338505050

Facility Contacts

Ruth Klaasen, MD, PhD

Role: primary

r.klaasen@menadermc.nl

0031338505050

Mihaela Gamala, MD

Role: backup

m.gamala@umcutrecht.nl

References

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.

Reference Type: DERIVED

PMID: 31504985 (View on PubMed)

Other Identifiers

NL54454.100.15

Identifier Type: -

Identifier Source: org_study_id