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NCT Number: NCT06383585

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

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.

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Key information

Conditions

Inflammatory Arthritis Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Naveen Murthy, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 3D DL oZTEo

Primary outcomes

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

    Time frame: 1 day

    The primary outcome

Secondary outcomes

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

    Time frame: 1 day

    The secondary outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Naveen S Murthy, MD

CONTACT

[email protected]

507-284-8548

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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