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

Inflammatory Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383585
• Other study ID #: 24-001367
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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