- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Djamal-Dine DJEDDI, Pr
- Telefonnummer: 33+322035590
- E-post: Djeddi.Djamal-Dine@chu-amiens.fr
Studieorter
-
-
-
Amiens, Frankrike, 80480
- Rekrytering
- CHRU Amiens
-
Kontakt:
- Djamal-Dine Djeddi, Pr
- Telefonnummer: 33+322087632
- E-post: djeddi.djamal-dine@chu-amiens.fr
-
Underutredare:
- Maud ULLMO ULLMO, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Aktiv komparator: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
variation of IRT measure between both groups
Tidsram: at baseline
|
variation of IRT measure between both groups |
at baseline
|
|
variation of IRT measure between both groups
Tidsram: at 1 month
|
variation of IRT measure between both groups |
at 1 month
|
|
variation of IRT measure between both groups
Tidsram: at 3 months
|
variation of IRT measure between both groups |
at 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
longitudinal changes in thermographic measurements
Tidsram: 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
Tidsram: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with functional parameters
Tidsram: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with biological parameters
Tidsram: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with clinical examination
Tidsram: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with ultrasounds
Tidsram: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with MRI
Tidsram: at 3 months
|
at 3 months
|
|
|
reproducibility of IRT measurements
Tidsram: at 3 months
|
at 3 months
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PI2026_843_0096
Plan för individuella deltagardata (IPD)
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