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

Primary Purpose

Rheumatoid Arthritis

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
thermal imaging
Sponsored by
North Florida Foundation for Research and Education
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • rheumatoid arthritis

Exclusion Criteria:

  • non complaince

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2021
    Last Updated
    November 17, 2021
    Sponsor
    North Florida Foundation for Research and Education
    Collaborators
    Vivadox, Infrared Cameras Incorporate
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05124990
    Brief Title
    Predictive Clinical Diagnosis of Rheumatoid Arthritis Flares Using Non-Invasive Infra-red Thermal Imaging and an AI/ML Algorithm
    Official Title
    Predictive Clinical Diagnosis of Rheumatoid Arthritis Flares Using Non-Invasive Infra-red Thermal Imaging and an AI/ML Algorithm
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    North Florida Foundation for Research and Education
    Collaborators
    Vivadox, Infrared Cameras Incorporate

    4. Oversight

    5. Study Description

    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.
    Detailed 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    thermal imaging
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Eligibility Criteria
    Inclusion Criteria: rheumatoid arthritis Exclusion Criteria: non complaince

    12. IPD Sharing Statement

    Learn more about this trial

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

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