3D MRI Technique for Rheumatoid Arthritis

Overseen By Naveen S Murthy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18 years

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the 3D DL oZTEo treatment for rheumatoid arthritis?

The research shows that advanced MRI techniques, like 3D imaging and contrast-enhanced MRI, are useful in assessing inflammation and joint damage in rheumatoid arthritis, which suggests that similar imaging techniques could be effective in evaluating and potentially guiding treatments like 3D DL oZTEo. ^{1 2 3 4 5}

How is the 3D DL Ozteo treatment different from other treatments for rheumatoid arthritis?

The 3D DL Ozteo treatment is unique because it uses advanced 3D MRI techniques to provide highly detailed images of the joints, which can help in early detection and management of rheumatoid arthritis by clearly visualizing inflammation and bone damage. This approach is more sensitive than traditional imaging methods, allowing for better monitoring of disease progression. ^{1 3 6 7 8}

What is the purpose of 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.

Research Team

Naveen Murthy, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with inflammatory arthritis, such as rheumatoid arthritis, who need their hand bones checked for damage. The study will use a new MRI technique to spot bone erosion.

Inclusion Criteria

I have had hand X-rays done in the last 3-6 months.

Scheduled for a hand MRI as part of their routine clinical care at Mayo Clinic Rochester

My X-rays show bone damage in my hands.

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Examination

Participants undergo MRI examination with the addition of the 3D DL oZTEo sequence to detect osseous changes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or complications following the MRI examination

1-2 weeks

Treatment Details

Interventions

• 3D DL Ozteo

Trial Overview The trial is testing a new MRI pulse sequence called 3D DL oZTEo. It's designed to better detect bone erosions in the hands of patients with inflammatory arthritis compared to current methods.

Participant Groups

Group I: oZTEo MRI pulse sequence Experimental Treatment 1 Intervention

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

3D DL Ozteo is already approved in European Union, United States for the following indications:

Approved in European Union as oZTEo for:

• Bone imaging
• Detection of osseous erosions
• Orthopedic imaging

Approved in United States as oZTEo for:

• Bone imaging
• Detection of osseous erosions
• Orthopedic imaging

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Findings from Research

Fat-suppressed gadolinium-enhanced MR imaging is effective in visualizing key lesions in rheumatoid arthritis, such as synovial proliferation and bone marrow inflammation, in a study of 38 wrists from 27 patients.

The scoring system developed to assess synovial enhancement (J-score) correlated well with C-reactive protein levels, indicating its potential usefulness in evaluating the inflammatory status of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-enhanced MR imaging of the wrist in rheumatoid arthritis: value of fat suppression pulse sequences. Nakahara, N., Uetani, M., Hayashi, K., et al.[2019]

Dynamic contrast-enhanced MRI (DCE-MRI) can accurately assess synovial inflammation in the knees of rheumatoid arthritis patients, showing strong correlations with histological inflammation grades based on biopsies from 17 patients.

Using semi-automatic image processing, the initial rate of enhancement (IRE) from specific manually outlined regions of interest (Quick ROI and Precise ROI) demonstrated high reliability and accuracy, while whole slice parameters were not effective for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic gadolinium-enhanced magnetic resonance imaging allows accurate assessment of the synovial inflammatory activity in rheumatoid arthritis knee joints: a comparison with synovial histology. Axelsen, MB., Stoltenberg, M., Poggenborg, RP., et al.[2016]

In a study of 25 rheumatoid arthritis patients, 3D MR maximum intensity projection (MIP) images effectively identified and located synovitis in the hand and wrist, demonstrating high sensitivity (91.07%) and specificity (98.57%).

The interobserver agreement for detecting synovitis was excellent for both 3D MIP (k=0.87) and contrast-enhanced MRI (k=0.91), indicating that 3D MIP is a reliable diagnostic tool that could enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of three-dimensional MR maximum intensity projection for the assessment of synovitis of the hand and wrist in rheumatoid arthritis: A pilot study. Li, X., Liu, X., Du, X., et al.[2015]

The 1.0-T extremity MRI system is as effective as the 1.5-T conventional MRI system in detecting synovial and bone changes in patients with rheumatoid arthritis, based on a study of 32 patients.

Patients reported a preference for the 1.0-T extremity MRI due to greater comfort, with 95.8% favoring this system over the conventional one.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 1.0-T extremity MR and 1.5-T conventional high-field-Strength MR in patients with rheumatoid arthritis. Naraghi, AM., White, LM., Patel, C., et al.[2009]

A study involving 18 patients with rheumatoid arthritis demonstrated that a new software can accurately measure wrist cartilage using contrast MRI, highlighting its potential for assessing joint health.

The research found a significant correlation between bone marrow edema (BME) and cartilage loss in specific wrist joints, indicating that BME may be a useful marker for monitoring cartilage deterioration in RA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cartilage quantification using contrast-enhanced MRI in the wrist of rheumatoid arthritis: cartilage loss is associated with bone marrow edema. Fujimori, M., Nakamura, S., Hasegawa, K., et al.[2018]

MRI is effective in diagnosing rheumatoid arthritis (RA), revealing key symptoms such as joint fluid accumulation, cartilage degeneration, and soft tissue inflammation in a study of 110 patients.

Compared to X-rays, MRI offers superior detection of inflammatory changes in the soft tissues of the joints, making it a valuable tool for assessing RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MR imaging in the diagnosis of rheumatoid arthritis]. Briukhanov, AV., Buevich, EI.[2016]

3T MRI provides clearer images of synovium, cartilage, bone, and soft tissue compared to 1.5T MRI, which enhances the ability to detect and manage early-stage rheumatoid arthritis (RA).

The improved sensitivity and spatial resolution of 3T MRI can help in understanding the mechanisms behind bone destruction in RA, potentially leading to better treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-tesla MR imaging of rheumatoid arthritis: implications for the mechanism of bone destruction]. Aoki, T., Korogi, Y.[2009]

MRI is highly effective for detecting various pathologies in rheumatoid arthritis (RA), such as synovitis and bone erosion, and is more sensitive than clinical exams and other imaging methods like X-rays and ultrasounds for monitoring disease activity and joint damage.

In patients with suspected RA, MRI can predict the development of the disease and potential structural damage, making it a valuable tool for diagnosis and monitoring in clinical practice and trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging in rheumatoid arthritis: the role of magnetic resonance imaging and computed tomography. Østergaard, M., Boesen, M.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Gadolinium-enhanced MR imaging of the wrist in rheumatoid arthritis: value of fat suppression pulse sequences. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Dynamic gadolinium-enhanced magnetic resonance imaging allows accurate assessment of the synovial inflammatory activity in rheumatoid arthritis knee joints: a comparison with synovial histology. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic performance of three-dimensional MR maximum intensity projection for the assessment of synovitis of the hand and wrist in rheumatoid arthritis: A pilot study. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of 1.0-T extremity MR and 1.5-T conventional high-field-Strength MR in patients with rheumatoid arthritis. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Cartilage quantification using contrast-enhanced MRI in the wrist of rheumatoid arthritis: cartilage loss is associated with bone marrow edema. [2018]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[MR imaging in the diagnosis of rheumatoid arthritis]. [2016]

7. Japan pubmed.ncbi.nlm.nih.gov

[Three-tesla MR imaging of rheumatoid arthritis: implications for the mechanism of bone destruction]. [2009]

8. Italy pubmed.ncbi.nlm.nih.gov

Imaging in rheumatoid arthritis: the role of magnetic resonance imaging and computed tomography. [2019]