3D DL Ozteo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis

NCT06383585 | Recruiting FDA Device

• 1 other identifier: 24-001367
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI.

Conditions

Inflammatory Arthritis

Outcome Measures

Primary Outcomes (1)

• The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.

  The primary outcome

  1 day

Secondary Outcomes (1)

• The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.

  1 day

Study Arms (1)

oZTEo MRI pulse sequence

EXPERIMENTAL

All patients will have the FDA approved MRI pulse sequence, oZTEo, added to their already ordered standard of care MRI examination.

Device: oZTEo

Interventions

oZTEo DEVICE

An FDA approved MRI pulse sequence, oZTEo, will be added to a standard of care MRI examination. The oZTEo pulse sequence will be anonymized and sent to GE Healthcare for the application of a deep learning algorithm, 3D DL.

Also known as: 3D DL oZTEo

oZTEo MRI pulse sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥18 years of age
• Hand radiographs performed within the past 3-6 months with imaging results available for analysis
• Hand radiographs confirm the presence of bony erosions
• Scheduled for a hand MRI as part of their routine clinical care at Mayo Clinic Rochester

You may not qualify if:

• \- Less than18 years of age

Sponsors & Collaborators

• Mayo Clinic: lead
• GE Healthcare: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Naveen Murthy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveen S Murthy, MD

CONTACT

507-284-8548; Murthy.Naveen@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: December 5, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)