Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease (THERMO-CROHN)
Primary Purpose
Crohn Disease, Infrared Thermography, Child
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
abdominal infrared radiation
Sponsored by
About this trial
This is an interventional screening trial for Crohn Disease focused on measuring Crohn Disease, Infrared thermography, Faecal Calprotectin, PCDAI, Child
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with CD according to the Porto criteria [6] Aged from 4 years to 17 years-old Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie) Child's affirmative agreement and assent and permission of their parents to participate in research Exclusion Criteria: Recent abdominal surgery Other Inflammatory bowel disease
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration
correlation between the quantification of abdominal infrared radiation determined by the FLIR® thermal camera and quantified by the spectral analysis of the thermal signal (in degrees Celsius) and the determination of faecal calprotectin concentration (µg/g of faeces). This concentration will be determined by ELISA method at Biochemistry in Amiens Picardie Faculty hospital.
Secondary Outcome Measures
Full Information
NCT ID
NCT05710276
First Posted
January 24, 2023
Last Updated
February 2, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05710276
Brief Title
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
Acronym
THERMO-CROHN
Official Title
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions.
In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI.
All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Infrared Thermography, Child
Keywords
Crohn Disease, Infrared thermography, Faecal Calprotectin, PCDAI, Child
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
abdominal infrared radiation
Intervention Description
In a specific room (controlled temperature and humidity) with a patient lying on his back, we will determine the abdominal infrared radiation with a FLIR® thermal camera (without contact) and quantify the thermal signal by spectral analysis (in degrees Celsius).
Primary Outcome Measure Information:
Title
correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration
Description
correlation between the quantification of abdominal infrared radiation determined by the FLIR® thermal camera and quantified by the spectral analysis of the thermal signal (in degrees Celsius) and the determination of faecal calprotectin concentration (µg/g of faeces). This concentration will be determined by ELISA method at Biochemistry in Amiens Picardie Faculty hospital.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with CD according to the Porto criteria [6]
Aged from 4 years to 17 years-old
Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie)
Child's affirmative agreement and assent and permission of their parents to participate in research
Exclusion Criteria:
Recent abdominal surgery
Other Inflammatory bowel disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DJAMAL-DINE DJEDDI, Pr
Phone
03.22.08.76.32
Email
djeddi.djamal-dine@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djamal-Dine Djeddi, MD
Phone
(33)322087632
Email
djeddi.djamal-dine@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Djamal-Dine Djeddi
Phone
(33)322087632
Email
djeddi.djamal-dine@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
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