NCT06383585

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Arthritis

Interventions

Type	Name	Description
DEVICE	oZTEo	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.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-04-25
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study