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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI method to improve images for people with hip replacements. The goal is to reduce metal artifacts (blurry spots) that often appear in MRI scans for these patients, making it easier for doctors to see the area clearly. Participants will undergo both the standard MRI and the new, modified MRI (also known as Optimized MRI) for comparison. This study may suit those who have had hip replacement surgery on one side, experience pain, and are already scheduled for an MRI.

As an unphased trial, this study offers participants the chance to contribute to advancements in MRI technology that could enhance diagnostic accuracy for future patients.

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 prior data suggests that this modified MRI is safe for patients with hip arthroplasty implants?

Research has shown that modified MRI techniques for hip arthritis are generally easy for patients to handle. No specific evidence indicates serious side effects from these improved MRI methods. Studies have aimed to enhance image quality by reducing issues caused by metal in patients with hip implants. The modified MRI changes the radiofrequency pulses to achieve this, without adding extra risks compared to regular MRI procedures.

Since this trial is in the "Not Applicable" phase, safety has been reasonably established, and the focus is on improving the technique rather than testing for safety. MRI, a non-invasive imaging method, is widely used, which adds to its safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the optimized MRI for hip arthritis because it offers a new way to look at joint damage. Unlike standard MRIs, this modified version uses advanced techniques to capture more detailed images. These sharper images can help doctors better understand the severity of hip arthritis and potentially lead to more personalized treatment plans. By comparing the standard and new MRI techniques, this approach could revolutionize how hip arthritis is diagnosed and managed, potentially leading to earlier and more accurate interventions.

What evidence suggests that this modified MRI is effective for hip arthritis?

Research shows that MRI scans effectively detect changes in cartilage, enhancing the understanding of hip arthritis. Some studies suggest using MRI to monitor changes in hip conditions over time. In this trial, participants will undergo both standard and new MRI techniques. The new MRI technique aims to reduce interference from metal in hip implants, resulting in clearer images. This improvement could help doctors better assess the hip joint. Overall, MRI has significantly advanced the study of joint health and arthritis. ^{1 3 6 7 8}

Who Is on the Research Team?

Iman Khodarahmi, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04875884

Optimized MRI of Patients With Hip Arthroplasty 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) ...

2. withpower.com withpower.com/trial/phase-joint-diseases-8-2021-dc7c6

Optimized MRI for Hip Arthritis 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) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9482955/

Current and Future Advanced Imaging Modalities for the ... Current research suggests that certain dGEMRIC and qMRI protocols could reliably diagnose pre-OA hip disease, but more research is necessary.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1063458415008420

OARSI Clinical Trials Recommendations: Hip imaging in ... Using MRI it is possible to accurately and feasibly measure change in cartilage morphometry over 12–18 months for hip OA and we recommend the use of MRI for ...

5. oarsijournal.com oarsijournal.com/article/S1063-4584(24)00027-X/fulltext

30 Years of MRI-based cartilage & bone morphometry in ... Over the past 30 years, MRI-based morphometry of cartilage and bone has contributed to a paradigm shift in understanding articular tissue physiology and OA ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04875884

Optimized MRI of Patients With Hip Arthroplasty 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) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6190779/

Imaging of osteoarthritis—recent research developments and ... Compositional MRI techniques show promise for predicting structural and clinical outcomes in OA research. Ultrasound can be a useful adjunct to radiography and ...

8. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.230531

MRI Advancements in Musculoskeletal Clinical and ... This review focuses on advances in musculoskeletal MRI, including continuous modifications in magnet, gradient, and radiofrequency coil designs ...