Fluorescence optical imaging in patients with juvenile rheumatic diseases
Organizational Data
- DRKS-ID:
- DRKS00012572
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-07-31
- Last update in DRKS:
- 2019-04-05
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
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.
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.
Health condition or problem studied
- ICD10:
- M08 - Juvenile arthritis
- ICD10:
- M25.5 - Pain in joint
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
Endpoints
- Primary outcome:
- Detection of inflammation in wrist and finger joints by clinical examination, sonographic examination and fluorescence optical imaging.
- Secondary outcome:
- Qualitative and quantitative assessment of fluorescence optical imaging findings in children and adolescents with inflammatory and non-inflammatory joint diseases
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Non-randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Vivantes Klinikum im Friedrichshain, Kinderklinik Berlin
- Medical center Vivantes Klinikum im Friedrichshain, Kinderklinik Berlin
- University medical center Charité Campus Virchow, SPZ Rheumatologie Berlin
- Medical center Helios Klinikum Berlin Buch, Kinderklinik Berlin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-10-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-06-30
- Target Sample Size:
- 100
- Final Sample Size:
- 96
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 6 Years
- Maximum Age:
- 18 Years
- 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
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
Addresses
Primary Sponsor
- Address:
- Vivantes Klinikum im FriedrichshainKlinik für Kinder- und JugendmedizinProf. Dr. Hermann GirschickLandsberger Allee 4910249 BerlinGermany
- Telephone:
- (030) 130 23 1572
- Fax:
- (030) 130 23 1381
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.http://www.vivantes.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Vivantes Klinikum im FriedrichshainProf. Dr. med. Hermann GirschickLandsberger Allee 4910249 BerlinGermany
- Telephone:
- 0049 30 130 23-1572
- Fax:
- 0049 30 130 23-1381
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Vivantes Klinikum im FriedrichshainProfessor Dr. med. Hermann GirschickLandsberger Allee 4910249 BerlinGermany
- Telephone:
- 0049 30 130 23-1572
- Fax:
- 0049 30 130 23-1381
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Vivantes Klinikum im FriedrichshainProf. Dr. med. Hermann GirschickLandsberger Allee 4910249 BerlinGermany
- Telephone:
- 0049 30 130 23-1572
- Fax:
- 0049 30 130 23-1381
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Pfizer PharmaLinkstr. 1010785 BerlinGermany
- Telephone:
- 0049 30 55 00 55-52975
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-11-01
- Ethics committee number:
- EA2/126/12
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-09-06
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Journal Publication
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry