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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06383585

Enrollment

Registered

2024-04-25

Start date

2024-12-05

Completion date

2026-12-31

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Arthritis

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.

Detailed description

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.

Interventions

DEVICEoZTEo

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

\- Less than18 years of age

Design outcomes

Primary

Measure	Time frame	Description
The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.	1 day	The primary outcome

Secondary

Measure	Time frame	Description
The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.	1 day	The secondary outcome

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNaveen Murthy, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026