Optimized MRI of Patients With Hip Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty.

- Referred for MRI examination at the discretion of the treating physician.

- Provision of signed and dated informed consent form.

- No metal hardware in the body including contralateral hip arthroplasty.

- No contraindication to MRI: defined as claustrophobia or presence of other MRI-incompatible devices.

Exclusion Criteria:

- History of revision hip arthroplasty.

- Pregnancy (self-reported, or self-suspected) - Hip arthroplasty surgery within one year of enrollment.

- Clinical indication to administer intravenous contrast material during MRI

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04875884
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Iman Khodarahmi, MD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hip Arthropathy

Additional Details

Twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.Primary Objective: To assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard MRI protocols. Secondary Objectives:

(1) To assess the visibility of normal structures between modified and standard MRI protocols.

(2) To assess the abnormality detection rate using modified and standard MRI protocols.

Arms & Interventions

Arms

Experimental: MRI group

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.

Interventions

Device: - Modified MRI

A technical modification to the standard MRI which only affects radiofrequency pulse polarization attempting to optimize the image quality. All other factors, including pulse sequence parameters, and patient and coil positioning is similar to that of the standard MRI.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

NYU Langone Radiology - Center for Biomedical Imaging

New York, New York, 10017

Site Contact

Iman Khodarahmi, MD

[email protected]

212-263-1379

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