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Rheumatoid Arthritis Handscanner Observational Study.
‘Ontstekingsdetectie met behulp van licht’.



- candidate number10912
- NTR NumberNTR3229
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2012
- Secondary IDs10-395/E / NL34559.041.10.v2 METC UMCU / CCMO
- Public TitleRheumatoid Arthritis Handscanner Observational Study.
‘Ontstekingsdetectie met behulp van licht’.
- Scientific TitleRA-HANDSCANNER OBSERVATIONAL STUDY.
- ACRONYMRA-HOS
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. Diagnosed with rheumatoid arthritis for groups II-IV;
2. Age range between 18 and 90 years;
3. Ability to give informed consent.
- Exclusion criteria1. Diagnosed with an inflammatory joint disease for group I;
2. Significant visual deformations of the hand and fingers;
3. Recent surgery or operation in the last three months on wrist, hand or fingers;
4. Wheelchair bound patients;
5. Pregnancy or breastfeeding;
6. Light sensitivity, i.e. Erythropoietic protoporphyria;
7. Allergy to Gadolinium contrast for group II;
8. Metal objects in any organ or joint for group II;
9. Renal insufficiency defined as MDRD < 30ml/min/1.73m2 for group II.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-jan-2012
- planned closingdate31-dec-2012
- Target number of participants70
- InterventionsN/A
- Primary outcomeThe primary objective of this study is to create an algorithm for the Full Handscan Proto.
- Secondary outcomeSecondary parameters are related to variables that may interfere with the optical measurements:
1. Effect of gadolinium i.v. on Full Hand Proto scanning after MRI testing;
2. Observed destruction and erosions in the joints of the hands and wrists, based on the most recent, or upcoming x-ray image as obtained during regular treatment;
3. Temperature;
4. Skin type (Caucasian, Mediterranean , Asian or Negroid);
5. Wounds;
6. Vasodilatative medication;
7. Vasoconstrictive diseases like Raynaud’s disease.
- TimepointsCross sectional first phase, monthly follow-up for patients with high initial disease activity during 6 months after cross sectional phase.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Wouter Rensen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.W.J. Bijlsma
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Akeso Medical Imaging, Regionaal Reumacentrum Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Akeso Medical Imaging
- PublicationsN/A
- Brief summaryObservational study to collect joint inflammation data in rheumatoid arthritis patients using a novel optical device and reference methods such as ultrasound and MRI. Data will be used to develop an data analysis algorithm for the optical device to visualize inflammation levels in hands and wrists of rheumatoid arthritis patients.
- Main changes (audit trail)
- RECORD11-jan-2012 - 26-jan-2012


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