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

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

Study Overview

• Status: Unknown
• Conditions: Gout
• Intervention / Treatment: Other: Dual Energy CT

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Amersfoort, Utrecht, Netherlands
      • Recruiting
      • Meander Medical Center
      • Contact: Ruth Klaasen, MD, PhD; Phone Number: 0031338505050; Email: r.klaasen@menadermc.nl
      • Contact: Mihaela Gamala, MD; Email: m.gamala@umcutrecht.nl
      • Principal Investigator: Ruth Klaasen, MD, PhD
      • Sub-Investigator: Mihaela Gamala, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity (95% CI) of DECT scanning for the detection of MSU deposits	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	VAS DECT, blind joint aspiration, ultrasound guided joint aspiration	2 weeks
correlation between cardiovascular risk and the urate volume on DECT	correlation coefficient between cardiovascular risk (SCORE European and ACC/AHA) and the urate volume on DECT	2 weeks
number of patients with clinical diagnosis gout 6 and 12 month after het DECT		6 and 12 month
number of patients on urate lowering medication 6 and 12 month after the DECT		6 and 12 month

Collaborators and Investigators

• Sponsor: Meander Medical Center
• Investigators: Principal Investigator: Ruth Klaasen, MD, PhD, Meander Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: September 17, 2016
• First Submitted That Met QC Criteria: January 28, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 17, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NL54454.100.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided