Trial document





This trial has been registered retrospectively.
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  DRKS00012572

Trial Description

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Title

Fluorescence optical imaging in patients with juvenile rheumatic diseases

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study was designed to evaluate the validity and reliability of a new imaging technique in rheumatology (fluorescence optical imaging, Rheumascan®) in children and adolescents with juvenile joint diseases. Patients with joint pain in the hands due to inflammatory and non-inflammatory causes are examined by the pediatric rheumatologist as well as by ultrasonography and Rheumascan® (one-time examination) and the respective findings are compared.

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Brief Summary in Scientific Language

Background: Valid detection of arthritis is essential in differential diagnosis of joint pain. ICG-enhanced fluorescence optical imaging (FOI) is a new imaging method that visualizes inflammation in wrist and finger joints.
Objectives: To compare FOI with ultrasonography (US, by gray-scale (GS) and power Doppler (PD)) and clinical examination (CE). To estimate the predictive power of FOI for discrimination between inflammatory and non-inflammatory joint diseases.
Methods: FOI and GSUS/PDUS were performed in both hands of 76 patients with joint pain (53 with juvenile idiopathic arthritis (JIA), 23 with non-inflammatory joint diseases). Inflammation was graded by a semiquantitative score (0–3) for each imaging method. Joints were defined clinically active if swollen or tender with limited range of motion. Sensitivity and specificity of FOI in 3 phases dependent on ICG enhancement (P1–3) were analyzed with CE and GSUS/PDUS as reference.
Results: For JIA patients, FOI had an overall sensitivity of 67.3%/72.0% and a specificity of 65.0%/58.8% with GSUS/PDUS as reference; specificity was highest in P3 (94.3%/91.7%). FOI was more sensitive for detecting clinically active joints than GSUS/PDUS (75.2% vs. 57.3%/32.5%). In patients with non-inflammatory joint diseases both FOI and US showed positive findings (25% and 14% of joints). The predictive value for discrimination between inflammatory and non-inflammatory joint diseases was 0.79 for FOI and 0.80/0.85 for GSUS/PDUS.
Conclusion: Dependent on the phase evaluated, FOI had moderate to good agreement with CE and US. Both imaging methods revealed limitations and should be interpreted cautiously. FOI may provide an additional diagnostic method in pediatric rheumatology.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012572
  •   2017/07/31
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  •   yes
  •   Approved
  •   EA2/126/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   M08 -  Juvenile arthritis
  •   M25.5 -  Pain in joint
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Interventions/Observational Groups

  •   This study prospectively assessed the diagnostic validity of fluorescence optical imaging for assessing inflammation in hand and finger joints of children with and without inflammatory rheumatic diseases in comparison to ultrasonography and clinical examination.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Detection of inflammation in wrist and finger joints by clinical examination, sonographic examination and fluorescence optical imaging.

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Secondary Outcome

Qualitative and quantitative assessment of fluorescence optical imaging findings in children and adolescents with inflammatory and non-inflammatory joint diseases

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/14
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   18   Years
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Additional Inclusion Criteria

- Children and adolescents aged 6 to 18 years affected by an inflammatory rheumatic disease (i.e., juvenile idiopathic arthritis [JIA]) or a non-inflammatory rheumatic disease (i.e., pain syndromes) affecting the hands and fingers

- Consent to participate in Xiralite® examination

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Exclusion Criteria

- allergy against ICG or iodine or Gadolinium
- hyperthyroidism
- pregnancy and breast feeding
- other known severe diseases
- chronic or active infection of the hands

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Addresses

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    • Vivantes Klinikum im FriedrichshainKlinik für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr.   Hermann  Girschick 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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    • Deutsches Rheuma-Forschungszentrum Berlin
    • Ms.  Prof. Dr. med.  Kirsten  Minden 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   0049 30 28460-669
    •   0049 30 28460-626
    •   Minden at drfz.de
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    • Helios-Klinikum Berlin BuchKlinik für Kinder- und Jugendmedizin
    • Mr.  Dipl. Med.  Ralf  Trauzeddel 
    • Schwanebecker Chaussee 50
    • 13125  Berlin
    • Germany
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    • Vivantes Klinikum im Friedrichshain
    • Mr.  Prof. Dr. med.  Hermann  Girschick 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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    • Vivantes Klinikum im Friedrichshain
    • Mr.  Professor Dr. med.  Hermann  Girschick 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Pfizer Pharma
    • Ms.  Jessica  Franke 
    • Linkstr. 10
    • 10785  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/30
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Trial Publications, Results and other Documents

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