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

NCT ID: NCT06383585

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

oZTEo MRI pulse sequence

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

Group Type EXPERIMENTAL

oZTEo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3D DL oZTEo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GE Healthcare

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naveen S. Murthy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naveen Murthy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Naveen S Murthy, MD

Role: CONTACT

507-284-8548

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Naveen Murthy, PHD

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-001367

Identifier Type: -

Identifier Source: org_study_id