- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07914179
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis (InfraAJI)
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, causing persistent joint inflammation, pain, and functional impairment. Current monitoring relies on clinical scores, laboratory markers, and imaging, which are often resource intensive. Infrared thermography (IRT) is a non-invasive, radiation-free method that detects skin temperature changes potentially reflecting joint inflammation. Evidence in pediatric populations is limited, but IRT could provide an objective, reproducible, and child-friendly tool. This study aims to evaluate IRT's diagnostic accuracy by comparing it with clinical scores, laboratory markers, and ultrasound Doppler, to assess its utility as a complementary monitoring tool.
Patients with JIA will undergo clinical examination, routine blood tests, and IRT at baseline, 1 month, and 3 months. Control patients will participate in a single IRT session and, a CRP/ESR/blood test; if a biological workup is already planned as part of their routine care, existing results will be collected, and no additional sampling will be performed. IRT will follow a standardized protocol, including an acclimatization period, predefined positioning, and acquisition of three consecutive images per joint. After completion of the study, JIA patients will resume their standard-of-care follow-up.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Djamal-Dine DJEDDI, Pr
- Telefoonnummer: 33+322035590
- E-mail: Djeddi.Djamal-Dine@chu-amiens.fr
Studie Locaties
-
-
-
Amiens, Frankrijk, 80480
- Werving
- CHRU Amiens
-
Contact:
- Djamal-Dine Djeddi, Pr
- Telefoonnummer: 33+322087632
- E-mail: djeddi.djamal-dine@chu-amiens.fr
-
Onderonderzoeker:
- Maud ULLMO ULLMO, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- children aged 2-16 years with clinically suspected arthritis affecting the knee, ankle, wrist, or hand, irrespective of disease stage,
- control group : children with non-inflammatory conditions and no history of autoimmune or inflammatory disease.
Exclusion Criteria:
- other inflammatory or non-inflammatory diseases or recent trauma/surgery explaining joint symptoms,
- local skin conditions interfering with infrared imaging, and treatments or comorbidities likely to alter joint or body temperature.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Patients with JIA
|
Patients with JIA will undergo a standardized evaluation including a clinical joint examination, routine blood tests (CRP, NFS, ionogram, liver function, coagulation), and IRT of selected joints |
|
Actieve vergelijker: Control patients
|
Control patients will undergo a single IRT session and a minimal blood test (CRP, ESP, blood count). IRT will be performed under controlled conditions with a defined joint positioning, 15-30 minutes of acclimatization, and acquisition of three consecutive images per joint. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
variation of IRT measure between both groups
Tijdsspanne: at baseline
|
variation of IRT measure between both groups |
at baseline
|
|
variation of IRT measure between both groups
Tijdsspanne: at 1 month
|
variation of IRT measure between both groups |
at 1 month
|
|
variation of IRT measure between both groups
Tijdsspanne: at 3 months
|
variation of IRT measure between both groups |
at 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
longitudinal changes in thermographic measurements
Tijdsspanne: at 3 months
|
longitudinal changes in thermographic measurements by comparing temperature differences (ΔT) between baseline (D0) and 3 months |
at 3 months
|
|
correlation of longitudinal changes in thermographic measurements with clinical parameters
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with functional parameters
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with biological parameters
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with clinical examination
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with ultrasounds
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with MRI
Tijdsspanne: at 3 months
|
at 3 months
|
|
|
reproducibility of IRT measurements
Tijdsspanne: at 3 months
|
at 3 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PI2026_843_0096
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .