IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

About

Brief 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.

Primary Purpose

Diagnostic

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

N/A

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