Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

Objective #1: To assess the clinical feasibility of implementing a novel, physician assisting, diagnostic approach for RA when compared to conventional RA examination and diagnostic procedures. This prospective, non-interventional study will assess clinically assess and diagnose the severity of RA in sero-positive RA patients experiencing active flares by using conventional examination and diagnostic methods, and compared those with a physician-assisting, diagnostic approach that involves the use of an infrared thermal imaging device, which detects heat waves to be correlated between RA patients and control subjects (i.e., those who do not have RA or who are in remission). Standard clinical laboratory values will be documented from the EHR system as well and will include ESR (sedimentation rate) and CRP (c-reactive protein). Objective #2: To develop and optimize a ML/Artificial intelligence(AI) algorithm that would process and analyze thermal images and assist in the predictive diagnosis of RA using the DAS-28 ESR score for those thermal images of the inflamed joints of patients. This study will predict the probability of an actual flare occurrence and its severity in RA patients by using an optimized, physician assisting ML/AI algorithm that processes and analyzes thermal images from sero-positive RA patients in pain and experiencing flares and that calculates the DAS-28 scoring system in real-time ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05124990
Study type Expanded Access
Source North Florida Foundation for Research and Education
Status No longer available

See also
  Status Clinical Trial Phase
Recruiting NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Recruiting NCT05112120 - Exploiting Leading Edge 7T MRI Brain Imaging to Decipher Olumiant's Mode of Analgesic Action in Rheumatoid Arthritis
Recruiting NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Not yet recruiting NCT05039372 - Rheumatoid Arthritis, Planned Behavıor Theory And Nurse Counselıng N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT01087125 - Abatacept Pregnancy Exposure Registry
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05051943 - A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4
Completed NCT01942174 - VACcination In Methotrexate Treated Rheumatoid Arthritis Patients Phase 3
Completed NCT03691909 - A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT02139345 - TC-A Registration Study N/A
Recruiting NCT04692493 - RA-PRO PRAGMATIC TRIAL Phase 2