- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07827443
mFFE MRI Versus CT for Cortical Bone Evaluation in Knee Osteoarthritis
Beyond Conventional MRI: Multi-Echo Fast Field Echo (mFFE) MRI for Cortical Bone Evaluation in Knee Osteoarthritis Compared With CT
Study Overview
Status
Conditions
Detailed Description
Knee osteoarthritis involves microstructural alterations in subchondral and cortical bone. Conventional MRI has limitations in visualizing cortical bone due to short T2 relaxation times. Multi-echo fast field echo (mFFE) sequences can produce CT-like images of cortical bone without ionizing radiation.
This observational study will include patients aged 40 years or older with clinically suspected or confirmed knee osteoarthritis. All participants will undergo both mFFE MRI and CT of the knee. The accuracy of mFFE MRI in detecting cortical bone degenerative changes will be compared with CT as the reference standard.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatima M Eltony, Resident
- Phone Number: +20 10 15712606
- Email: fatima.18313255@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Age 40 years or older
- Clinically suspected or confirmed knee osteoarthritis
- Able and willing to provide informed consent
Exclusion Criteria:
- - Implanted electronic devices (pacemakers, ICDs, neurostimulators, cochlear implants)
- Metallic foreign bodies in the eyes or orbits
- Ferromagnetic cerebral aneurysm clips
- Implantable infusion pumps
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Single cohort: Patients with knee osteoarthritis
Patients aged 40 years or older with knee osteoarthritis who will undergo both multi-echo fast field echo (mFFE) MRI and CT of the knee for comparison of cortical bone evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of mFFE MRI for cortical bone changes
Time Frame: Baseline
|
Overall diagnostic accuracy percentage of multi-echo fast field echo MRI in detecting cortical bone degenerative changes in knee osteoarthritis, using CT as the reference standard
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of mFFE MRI for cortical bone changes
Time Frame: Baseline
|
Sensitivity percentage of multi-echo fast field echo MRI in detecting cortical bone degenerative changes in knee osteoarthritis, using CT as the reference standard
|
Baseline
|
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Specificity of mFFE MRI for cortical bone changes
Time Frame: Baseline
|
Specificity percentage of multi-echo fast field echo MRI in detecting cortical bone degenerative changes in knee osteoarthritis, using CT as the reference standard
|
Baseline
|
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Detection of subchondral sclerosis
Time Frame: Baseline
|
Number of cases in which mFFE MRI correctly identifies subchondral sclerosis compared with CT
|
Baseline
|
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Detection of osteophytes
Time Frame: Baseline
|
Number of cases in which mFFE MRI correctly identifies osteophytes compared with CT
|
Baseline
|
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Detection of joint space narrowing
Time Frame: Baseline
|
Number of cases in which mFFE MRI correctly identifies joint space narrowing compared with CT
|
Baseline
|
|
Image quality score
Time Frame: Baseline
|
Mean subjective image quality score of mFFE MRI for cortical bone visualization on a predefined scale from 1 to 5, with higher scores indicating better image quality
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ehab M Mohammed, prof, Diagnostic and interventional radiology Department, Assiut University Hospitals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mFFE-MRI-KneeOA-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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