Inflammatory ArthritisNCT06383585
3D DL Ozteo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis
A study testing oZTEo in people with Inflammatory Arthritis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- oZTEo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of 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.
Read the 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.
- Conditions
- Inflammatory Arthritis
- Being tested
- oZTEo
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oZTEoDevice
Also called 3D DL 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.
| Study group | Role | What they receive |
|---|---|---|
| oZTEo MRI pulse sequence | Experimental | All patients will have the FDA approved MRI pulse sequence, oZTEo, added to their already ordered standard of care MRI examination. Receives: Device: oZTEo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence.
The secondary outcome
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start5 Dec 2024
- Primary completion10 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Naveen S. Murthy, Mayo Clinic
- Investigators
- Naveen Murthy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383585
- Sponsor's protocol ID
- 24-001367
- Status last verified
- Aug 2026
- First submitted
- 22 Apr 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D DL oZTEo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT06383585
- Acronym / sponsor ID
- 24-001367
- Conditions
- Inflammatory Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oZTEo MRI pulse sequence | Experimental | Device: oZTEoAll patients will have the FDA approved MRI pulse sequence, oZTEo, added to their already ordered standard of care MRI examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Less than18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oZTEoAlso: 3D DL oZTEoAn 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. | Device | oZTEo MRI pulse sequence |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Murthy, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oZTEo in people with Inflammatory Arthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.