IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

Lucas R. Cusumano, MD

Status: Begins enrollment in 2 months

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

Treatments: Device: Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT07494838

25-2531

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment

Other group

Description:

Treatment with GAE

Treatment:

Device: Embolization