Optimized MRI for Hip Arthritis

Overseen By Iman Khodarahmi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Revision hip arthroplasty, Pregnancy, Recent surgery, others

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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Optimized MRI for Hip Arthritis?

Research shows that using advanced MRI techniques, like high-field systems and specialized coils, can provide detailed images of hip structures. This helps in accurately assessing arthritis-related changes, which can improve diagnosis and treatment planning. ^{1 2 3 4 5}

Is Optimized MRI safe for humans?

The research articles do not provide specific safety data for Optimized MRI, but they do involve MRI techniques used in humans without reporting safety concerns, suggesting general safety in similar contexts. ^{2 3 4 6 7}

How is the treatment 'Optimized MRI for Hip Arthritis' different from other treatments for hip arthritis?

Optimized MRI for Hip Arthritis is unique because it uses advanced MRI techniques, like radiofrequency pulse polarization optimization, to provide high-resolution images of the hip joint. This allows for better visualization of arthritis features such as synovitis (inflammation of the joint lining) and cartilage changes, which can improve diagnosis and treatment planning compared to standard imaging methods. ^{2 4 5 8 9}

Research Team

Iman Khodarahmi, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with hip arthritis who have had a hip replacement on one side and are experiencing symptoms like pain. They must be able to undergo MRI scans, meaning no severe claustrophobia or other metal implants, and not pregnant. Those with recent hip surgery or needing contrast material for MRI can't participate.

Inclusion Criteria

Provision of signed and dated informed consent form

No metal hardware in the body including contralateral hip arthroplasty

Your doctor thinks you need an MRI.

Exclusion Criteria

I have had a hip replacement revision surgery.

I had hip replacement surgery within the last year.

Pregnancy (self-reported, or self-suspected)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo both standard and modified MRI techniques to compare effectiveness in reducing metal-related artifacts

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Modified MRI

Trial Overview The study tests an optimized MRI technique designed to reduce image distortion caused by metal from hip replacements. Participants will receive two MRIs: one using standard settings and another with the modified approach that optimizes radiofrequency pulse polarization.

Participant Groups

Group I: MRI group Experimental Treatment 1 Intervention

Subjects enrolled in this study will undergo both standard and new MRI techniques. The standard MRI is needed for your routine care and as ordered by the referring doctor. The new MRI is performed for research purposes. Participants will be imaged with both methods and the results will be compared.

Modified MRI is already approved in United States, European Union for the following indications:

Approved in United States as Modified MRI for:

• Evaluation of hip arthroplasty implants
• Reduction of metal-related artifacts

Approved in European Union as Optimized MRI for:

• Assessment of periprosthetic soft tissues
• Detection and evaluation of osteolysis

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

ISS, Inc.

Industry Sponsor

Trials

3

Recruited

340+

Findings from Research

Using a pelvic phased-array coil for MRI imaging of the hip provides high-resolution images that clearly delineate the acetabular labrum and articular cartilage.

In a study involving seven hips, the pelvic coil outperformed body and flexible-surface coils, suggesting it may enhance diagnostic accuracy in hip assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High resolution MR imaging of the hip using pelvic phased-array coil]. Niitsu, M., Mishima, H., Itai, Y.[2011]

Intravenous gadolinium does not significantly affect T2 or T2* relaxation times in hip cartilage but enhances the quality of morphological imaging at 7-T MRI, making it easier to distinguish between cartilage and joint fluid.

The study involved 11 healthy volunteers and demonstrated that gadolinium improves the delineation of acetabular and femoral cartilage, allowing for combined morphological and quantitative assessments in a single examination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphological imaging and T2 and T2* mapping of hip cartilage at 7 Tesla MRI under the influence of intravenous gadolinium. Lazik-Palm, A., Kraff, O., Geis, C., et al.[2020]

In a study of 121 patients undergoing MRI for suspected sacroiliitis, the use of a phased array body coil significantly improved image quality compared to a surface coil, enhancing the ability to identify bone marrow edema patterns.

Motion-resistant T2-weighted sequences combined with the phased array body coil resulted in the highest inter-reader agreement and the fewest indeterminate zones, indicating a more reliable evaluation of sacroiliac joints in patients with spondyloarthropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol optimization of sacroiliac joint MR Imaging at 3 Tesla: Impact of coil design and motion resistant sequences on image quality. Gondim Teixeira, PA., Bravetti, M., Hossu, G., et al.[2019]

7-Tesla MRI successfully provided high-resolution images of both hips in 12 subjects, including volunteers and patients with avascular necrosis, demonstrating its potential for detailed anatomical and pathological assessment.

The CP2+ shim mode was found to be the most effective for imaging, while the DESS sequence showed the best robustness against B1 inhomogeneities, making it particularly useful for visualizing anatomical details and pathological changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral hip imaging at 7 Tesla using a multi-channel transmit technology: initial results presenting anatomical detail in healthy volunteers and pathological changes in patients with avascular necrosis of the femoral head. Theysohn, JM., Kraff, O., Orzada, S., et al.[2021]

MRI is a versatile tool for assessing both inflammatory arthritis and osteoarthritis, with various systems available that cater to different imaging needs, from low-cost extremity units to advanced 7-T whole-body systems.

Novel MRI techniques can effectively quantify disease levels in arthritis, allowing for detailed visualization of key features such as synovitis and cartilage changes, which can enhance diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing MRI for imaging peripheral arthritis. Hodgson, RJ., O'Connor, PJ., Ridgway, JP.[2012]

The MAVRIC SL MRI sequence significantly reduces metal artifacts compared to the 2D FSE sequence, with a 59.9% reduction at the hip and 31.3% at the femur, improving image clarity for patients with hip arthroplasty.

MAVRIC SL not only decreases artifact scores but also enhances the depiction of anatomical details and abnormal findings, leading to increased diagnostic confidence for radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal artifact reduction with MAVRIC SL at 3-T MRI in patients with hip arthroplasty. Choi, SJ., Koch, KM., Hargreaves, BA., et al.[2020]

The study involved 40 symptomatic patients with hip joint deformities and 31 asymptomatic controls, using high-resolution 3D delayed gadolinium-enhanced magnetic resonance imaging (dGEMRIC) to assess cartilage health.

Results showed that the control group had significantly higher T1Gd values, indicating better cartilage quality, compared to the patient group, highlighting the effectiveness of dGEMRIC in detecting cartilage degeneration in hip joint disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional delayed gadolinium-enhanced magnetic resonance imaging of hip joint cartilage at 3T: a prospective controlled study. Zilkens, C., Miese, F., Kim, YJ., et al.[2016]

The study successfully demonstrated the feasibility of simultaneous bilateral hip imaging at 7 Tesla, which is expected to improve the diagnostic accuracy for early hip diseases due to enhanced tissue contrast and spatial resolution.

Using a 16-channel stripline transceiver RF coil and a B1 shimming algorithm, the researchers effectively reduced signal inhomogeneities, allowing for high-quality imaging of both hips while minimizing RF power requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous bilateral hip joint imaging at 7 Tesla using fast transmit B₁ shimming methods and multichannel transmission - a feasibility study. Ellermann, J., Goerke, U., Morgan, P., et al.[2021]

The study successfully developed a direct magnetic resonance arthrography (DMRA) technique for the hip using a conventional 1.5 Tesla MRI scanner, demonstrating its feasibility without the need for X-ray fluoroscopy.

In a trial with five patients, the procedure was successful in all cases, achieving diagnostic quality images, and the time for the procedure decreased significantly with experience, indicating improved efficiency in performing DMRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided direct arthrography of the hip. Graves, MJ., Wakely, S., Bearcroft, PW., et al.[2013]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[High resolution MR imaging of the hip using pelvic phased-array coil]. [2011]

2. Germany pubmed.ncbi.nlm.nih.gov

Morphological imaging and T2 and T2* mapping of hip cartilage at 7 Tesla MRI under the influence of intravenous gadolinium. [2020]

3. France pubmed.ncbi.nlm.nih.gov

Protocol optimization of sacroiliac joint MR Imaging at 3 Tesla: Impact of coil design and motion resistant sequences on image quality. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Bilateral hip imaging at 7 Tesla using a multi-channel transmit technology: initial results presenting anatomical detail in healthy volunteers and pathological changes in patients with avascular necrosis of the femoral head. [2021]

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

Optimizing MRI for imaging peripheral arthritis. [2012]

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

Metal artifact reduction with MAVRIC SL at 3-T MRI in patients with hip arthroplasty. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Three-dimensional delayed gadolinium-enhanced magnetic resonance imaging of hip joint cartilage at 3T: a prospective controlled study. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Simultaneous bilateral hip joint imaging at 7 Tesla using fast transmit B₁ shimming methods and multichannel transmission - a feasibility study. [2021]

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

MR-guided direct arthrography of the hip. [2013]