Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies

Allergy Clinical Trial

— SPAT_AI  

Official title:

Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918354
• Other study ID #: HDX003
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Hippocreates
• Contact: Mark Jorissen, MD, PhD
• Phone: 003216336381
• Email: mark.jorissen[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test.

In this study 700 images will be collected to develop the AI model, an additional 200 images will be collected to evaluate performance of the AI model. In a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the S.P.A.T. AI medical software.

The primary endpoint is the accuracy of the maximal wheal size measurement by S.P.A.T. AI versus the maximal wheal size measurement by the physician.

It is a prospective multicentric study that will include 1000 study participants from different countries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.

Exclusion Criteria:

• Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment

• Use of antihistaminic medication < 7 days before the start of the study

• Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study

• Use of topical corticoids on the forearm < 7 days before the start of the study

• Use of Omalizumab < 6 months before the start of the study

• Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)

• Incapacitated individuals

• Individuals who do not speak the local language (Dutch - French)

• Individuals who cannot read or write

Related Conditions & MeSH terms

• Allergy

Intervention

Device:
• Skin Prick Automated Test
Detection of sensitisation to specific allergens via the skin prick automated test.

Locations

Country	Name	City	State
Belgium	Clinique Universitaires Saint-Luc	Brussels
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liège
Belgium	GZA ziekenhuizen	Wilrijk
Germany	Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Hippocreates

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalency of S.P.A.T. artificial intelligence versus physician	The equivalency of the maximal wheal diameter as measured by S.P.A.T. AI versus the maximal wheal diameter as assessed by the physician.	15 minutes after the diagnostic test
Secondary	Precision of S.P.A.T. artificial intelligence versus physician	Likelihood that the S.P.A.T. AI maximal wheal diameter measurement lays within the range of the maximal wheal size measurement of 3 independent physicians.	15 minutes after the diagnostic test
Secondary	Intra-reader variability of S.P.A.T. read out by physicians	Variation in maximal wheal size diameter of the same image by 3 independent physicians.	15 minutes after the diagnostic test
Secondary	Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician	Accuracy of the maximal wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.	15 minutes after the diagnostic test
Secondary	Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician	Inter-reader variability of read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.	15 minutes after the diagnostic test
Secondary	Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician	Total time required to perform read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.	15 minutes after the diagnostic test
Secondary	Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician	Accuracy of mean wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.	15 minutes after the diagnostic test
Secondary	Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician	Accuracy of wheal area by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.	15 minutes after the diagnostic test
Secondary	Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician	Accuracy of HEP-index measurement by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.	15 minutes after the diagnostic test