- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Djamal-Dine DJEDDI, Pr
- Telefonnummer: 33+322035590
- E-post: Djeddi.Djamal-Dine@chu-amiens.fr
Studiesteder
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Amiens, Frankrike, 80480
- Rekruttering
- CHRU Amiens
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Ta kontakt med:
- Djamal-Dine Djeddi, Pr
- Telefonnummer: 33+322087632
- E-post: djeddi.djamal-dine@chu-amiens.fr
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Underetterforsker:
- Maud ULLMO ULLMO, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Patients with JIA
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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 |
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Aktiv komparator: Control patients
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
variation of IRT measure between both groups
Tidsramme: at baseline
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variation of IRT measure between both groups |
at baseline
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variation of IRT measure between both groups
Tidsramme: at 1 month
|
variation of IRT measure between both groups |
at 1 month
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variation of IRT measure between both groups
Tidsramme: at 3 months
|
variation of IRT measure between both groups |
at 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
longitudinal changes in thermographic measurements
Tidsramme: at 3 months
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longitudinal changes in thermographic measurements by comparing temperature differences (ΔT) between baseline (D0) and 3 months |
at 3 months
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correlation of longitudinal changes in thermographic measurements with clinical parameters
Tidsramme: at 3 months
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at 3 months
|
|
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correlation of longitudinal changes in thermographic measurements with functional parameters
Tidsramme: at 3 months
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at 3 months
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correlation of longitudinal changes in thermographic measurements with biological parameters
Tidsramme: at 3 months
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at 3 months
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correlation of diagnostic performance of IRT with clinical examination
Tidsramme: at 3 months
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at 3 months
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correlation of diagnostic performance of IRT with ultrasounds
Tidsramme: at 3 months
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at 3 months
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correlation of diagnostic performance of IRT with MRI
Tidsramme: at 3 months
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at 3 months
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reproducibility of IRT measurements
Tidsramme: at 3 months
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at 3 months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI2026_843_0096
Plan for individuelle deltakerdata (IPD)
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