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Not Yet Recruiting NCT07494838

IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

Conditions: Knee Osteoarthritis, Knee Discomfort, Knee Pain Chronic, Knee Swelling Pain

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Lucas R. Cusumano, MD

Location: University of California, Los Angeles Los Angeles California

Summary

Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.

Eligibility Criteria

Inclusion Criteria: * Provided informed consent * Age ≥ 40 years * Ineligibility for or refusal of surgical management * Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10 * Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date * Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months * Able to comply with all treatments and protocol follow-up visits Exclusion Criteria: * Mild knee pain as determined by visual analog scale \< 5 out of 10 * OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation * Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min. * Significant arterial atherosclerosis that would limit selective angiography * History of fibromyalgia, autoimmune, or inflammatory disorder * History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine * Allergy to iodinated contrast agents * Active infection or malignancy * Recent (within 12 months) or active cigarette use * Prior total or partial knee replacement in the subject knee * Active pregnancy * Uncorrectable bleeding diathesis * Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07494838). StuddyBuddy aggregates publicly available trial information.