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Extended report
Inflammation assessment in patients with arthritis using a novel in vivo fluorescence optical imaging technology
  1. Stephanie G Werner1,
  2. Hans-Eckhard Langer1,
  3. Sarah Ohrndorf2,
  4. Malte Bahner3,
  5. Peter Schott4,
  6. Carsten Schwenke5,
  7. Michael Schirner3,
  8. Hans Bastian2,
  9. Gudrun Lind-Albrecht1,
  10. Bernward Kurtz4,
  11. Gerd R Burmester2,
  12. Marina Backhaus2
  1. 1RHIO (Rheumatology, Immunology, Osteology) Center Duesseldorf and RHIO Research Institute, Duesseldorf, Germany
  2. 2Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany
  3. 3mivenion GmbH, Berlin, Germany
  4. 4Department of Radiology, Evangelisches Krankenhaus Duesseldorf, Duesseldorf, Germany
  5. 5SCOSSIS Statistical Consulting, Berlin, Germany
  1. Correspondence to Gerd R Burmester, Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Charitéplatz 1, D-10117 Berlin, Germany; gerd.burmester{at}charite.de

Abstract

Background Indocyanine green (ICG)-enhanced fluorescence optical imaging (FOI) is an established technology for imaging of inflammation in animal models. In experimental models of arthritis, FOI findings corresponded to histologically proven synovitis. This is the first comparative study of FOI with other imaging modalities in humans with arthritis.

Methods 252 FOI examinations (Xiralite system, mivenion GmbH, Berlin, Germany; ICG bolus of 0.1 mg/kg/body weight, sequence of 360 images, one image per second) were compared with clinical examination (CE), ultrasonography (US) and MRI of patients with arthritis of the hands.

Results In an FOI sequence, three phases could be distinguished (P1–P3). With MRI as reference, FOI had a sensitivity of 76% and a specificity of 54%, while the specificity of phase 1 was 94%. FOI had agreement rates up to 88% versus CE, 64% versus greyscale US, 88% versus power Doppler US and 83% versus MRI, depending on the compared phase and parameter. FOI showed a higher rate of positive results compared to CE, US and MRI. In individual patients, FOI correlated significantly (p<0.05) with disease activity (Disease Activity Score 28, r=0.41), US (r=0.40) and RAMRIS (Rheumatoid Arthritis MRI Score) (r=0.56). FOI was normal in 97.8% of joints of controls.

Conclusion ICG-enhanced FOI is a new technology offering sensitive imaging detection of inflammatory changes in subjects with arthritis. FOI was more sensitive than CE and had good agreement with CE, US in power Doppler mode and MRI, while showing more positive results than these. An adequate interpretation of an FOI sequence requires a separate evaluation of all phases. For the detection of synovitis and tenosynovitis, FOI appears to be as informative as 1.5 T MRI and US.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl

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Footnotes

  • H-EL and SO contributed equally

  • Funding This study was supported by BMBF project “ArthroMark”, subproject no. 7 “Clinical study on Biomarkers and Imaging”. One of the technical devices (FOI) was provided via an unrestricted educational grant by Pfizer Company, Berlin, Germany. Statistical analysis was funded by mivenion GmbH, Berlin, Germany.

  • Competing interests M Schirner and M Bahner are shareholders of mivenion GmbH.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the ethics committee of the Charité University Clinic Berlin.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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