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

ConditionInflammatory Arthritis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: oZTEo MRI pulse sequenceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

1 day

Secondary outcomes

The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.

The secondary outcome

Time frame

1 day

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

GE Healthcare

Collaborator

Source ClinicalTrials.gov

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