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

Not Applicable

Recruiting

• Conditions: Inflammatory Arthritis
• Interventions: Device: oZTEo

• Registration Number: NCT06383585
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-25
• Status Verified: 2024-12
• Study Start: 2024-12-05
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-06-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States