Predictive Clinical Diagnosis of Rheumatoid Arthritis Flares Using Non-Invasive Infra-red Thermal Imaging and an AI/ML Algorithm

NCT05124990 | Unknown

• 1 other identifier: 202102571
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The hypothesis for this clinical research project is that the severity of RA may be detected and predicted using an optimized ML/AI algorithm that uses infrared thermal images of inflamed joints and standard clinical RA-related markers (i.e., ESR and CRP) by computing DAS-28 ESR scores in real-time. The infrared thermal images coupled with clinical laboratory markers and the ML/AI algorithm are expected to assist a practicing clinician in the RA diagnosis and the prediction of the occurrence of flares in RA patients. Physicians who use this technology, would need minimum training and will be able to accurately and reliably diagnose RA using a cheaper method which does not involve incident radiation emitted by other imaging modalities such a X-RAY, musculoskeletal (MSK) ultrasound, or a magnetic resonance imaging (MRI). The aim would be to have the Infrared thermal imaging devices at remote VA clinics that do not have a rheumatology specialist where veterans can go for their inflammatory arthritis flare and get this image by the local VA RN. These clinical results can then be assessed by and discussed with a Rheumatologist via telehealth visits.

Conditions

Rheumatoid Arthritis

Interventions

thermal imaging DIAGNOSTIC_TEST

no risk infrared thermal image would be used to capture pictures of the patients joints that are reported to be painful during a rheumatoid arthritis flare along iwth labs such as esr and crp. these will then be fed to a machine learning algorithm that will learn to predict the DAS 28 score for the RA patient and their flare.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rheumatoid arthritis

You may not qualify if:

• non complaince

Sponsors & Collaborators

• North Florida Foundation for Research and Education: lead
• Vivadox: collaborator
• Infrared Cameras Incorporate: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rheumatologist, Staff Physician MD

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 18, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11