- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Djamal-Dine DJEDDI, Pr
- Phone Number: 33+322035590
- Email: Djeddi.Djamal-Dine@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- Recruiting
- CHRU Amiens
-
Contact:
- Djamal-Dine Djeddi, Pr
- Phone Number: 33+322087632
- Email: djeddi.djamal-dine@chu-amiens.fr
-
Sub-Investigator:
- Maud ULLMO ULLMO, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
variation of IRT measure between both groups
Time Frame: at baseline
|
variation of IRT measure between both groups |
at baseline
|
|
variation of IRT measure between both groups
Time Frame: at 1 month
|
variation of IRT measure between both groups |
at 1 month
|
|
variation of IRT measure between both groups
Time Frame: at 3 months
|
variation of IRT measure between both groups |
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
longitudinal changes in thermographic measurements
Time Frame: 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
Time Frame: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with functional parameters
Time Frame: at 3 months
|
at 3 months
|
|
|
correlation of longitudinal changes in thermographic measurements with biological parameters
Time Frame: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with clinical examination
Time Frame: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with ultrasounds
Time Frame: at 3 months
|
at 3 months
|
|
|
correlation of diagnostic performance of IRT with MRI
Time Frame: at 3 months
|
at 3 months
|
|
|
reproducibility of IRT measurements
Time Frame: at 3 months
|
at 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2026_843_0096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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