IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

NCT07494838 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-2531
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Pain Chronic; Knee Swelling Pain; Knee Osteoarthritis; Knee Discomfort

Keywords

GAE

Outcome Measures

Primary Outcomes (1)

• Compare metabolic activity

  To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and incidence of clinical response in patients undergoing GAE as defined as a 50% reduction in Western Ontario and McMaster Universities Arthritis Index (WOMAC).

  Screening, Month 6

Secondary Outcomes (6)

• Associate changes in metabolic activity detected by PET

  Screening, Month 6

• Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration

  Screening, Month 6

• Safety of GAE

  Treatment, Month 3, Month 6, Month 12

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Treatment Efficacy

  Screen, Month 3, Month 6, Month 12

• Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy

  Screen, Month 3, Month 6, Month 12

Study Arms (1)

Treatment

OTHER

Treatment with GAE

Device: Embolization

Interventions

Embolization DEVICE

Genicular artery embolization

Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucas R. Cusumano, MD: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Lucas Cusumano, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshia Mian, BS

CONTACT

310-906-6028; ammian@mednet.ucla.edu

Lucas Cusumano, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Radiologist, Assistant Clinical Professor

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)