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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06383585
Status
Recruiting
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Conditions

  • Inflammatory Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 5, 2024
Status verified
Dec 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence. [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Naveen Murthy, PHD

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Mayo Clinic in Rochester· Rochester, MN

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