Automated Arthritis Detection Using Artificial Intelligence on Smartphone Photographs (AISynovitis)

December 19, 2024 updated by: Med2Measure

Automated Detection Methods for Inflammatory Arthritis and Formation of an Image Database

The investigators are testing the ability of convolutional neural networks (CNNs), that is artificial intelligence, on smartphone photographs in detecting inflammatory arthritis. This promises to be an efficient, accurate, and non-invasive diagnostic tool that will significantly improve early detection and management of inflammatory arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Over the past 4 years the investigators have aimed to help the early detection of arthritis leveraging artificial intelligence. This project aims to detect arthritis based on smart phone photographs of joint areas that make it scalable and available in the community. This group first developed a compelling proof-of-concept pipeline and models using 100 patients. (published in Frontiers in Medicine, Nov 2023, wherein they demonstrated that this technology works with reasonable accuracy in the lab, viz Technology Readiness Level currently stands at 3-4). They followed with a newer paper (submitted for publication, available on preprint server MedRxiv) that trained two different CNNs, a screening CNN on uncropped hands that distinguishes patients from controls followed by joint specific detections.

The system involves supporting infrastructure that will enable efficient detection of arthritis. This includes

  1. Collection of photos in a standardized manner using custom designed boxes
  2. Using and testing a browser pipeline
  3. The CNN models will be trained on the dataset of photographs taken in this and results will be deployed to doctors in the community. This ensures a doctor in the loop that can later take action on the results for further confirmatory tests or management.
  4. Understanding knowledge, attitude of patients and doctors towards AI in clinical decision making algorithms

This is a Prospective, non-interventional study and this project only involves an investigator taking a smartphone photograph of some joint areas kept in standardized positions. This involves no risk to the patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Pune, India, 411001
        • Poona Superspeciality Clinic
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Rheumatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients with inflammatory arthritis. This can include but is not limited to rheumatoid arthritis, lupus, psoriatic arthritis, peripheral spondyloarthritis, viral arthritis.

Description

Inclusion Criteria:

  • Inflammatory arthritis of any etiology

Exclusion Criteria:

  • Severe deformity that hampers standardization of photographs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Inflammatory arthritis
Patients with inflammatory arthritis regardless of etiology including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis and viral arthritis
Diagnostic test: AI assisted smartphone diagnosis
Patients will examination and clinical photographs for convolutional networks to diagnose inflammatory arthritis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of AI diagnosis against specialist (rheumatologist) opinion
Time Frame: 3 years
Concordance of detection of synovitis by convolutional neural network (binary) with a clinically diagnosed specialist opinion (rheumatologist opinion)
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of AI diagnosis against imaging diagnosis on Ultrasound
Time Frame: 3 years
Concordance of detection of synovitis by convolutional neural network (binary) compared to musculoskeletal ultrasound
3 years
Sensitivity to change
Time Frame: 3 years
Can the convolutional neural network detect change from an inflamed to an non-inflamed joint
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Med2Measure

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IISER Pune

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanat Phatak, MD, DM, Med2Measure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2M-ID0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified photographs and clinical information excluding HIPAA variables

IPD Sharing Time Frame

January 2027-January 2028

IPD Sharing Access Criteria

Researchers with a scientific plan can get in touch with the principal investigator with a brief note.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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