IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

March 21, 2026 updated by: Lucas R. Cusumano, MD
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lucas Cusumano, MD

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
Treatment with GAE
Device: Embolization
Genicular artery embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare metabolic activity
Time Frame: Screening, Month 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associate changes in metabolic activity detected by PET
Time Frame: Screening, Month 6
To compare change in metabolic activity detected by PET/MRI as defined as percentage change in maximum standardized uptake value (SUVmax) and change of pain over time defined as percent change in Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Screening, Month 6
Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration
Time Frame: Screening, Month 6
To compare spatial association between MRI Osteoarthritis Knee Score (MOAKS) defined structural abnormalities and metabolic activity. For each subregion, MOAKS scores (cartilage loss and BML size) are graded semi-quantitatively (0 to 3, with higher score representing worse disease) and paired with corresponding standardized uptake value (SUVmax) values derived from co-registered PET data.
Screening, Month 6
Safety of GAE
Time Frame: Treatment, Month 3, Month 6, Month 12

Outcome measure: Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety

Measurement description: Treatment-related adverse events from genicular artery embolization during the study period
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
Time Frame: Screen, Month 3, Month 6, Month 12

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations.

Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
Screen, Month 3, Month 6, Month 12
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy
Time Frame: Screen, Month 3, Month 6, Month 12
The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).
Screen, Month 3, Month 6, Month 12
Assess KOOS5
Time Frame: Screen, Month 3, Month 6, Month 12

Change From Baseline in Knee injury and Osteoarthritis Outcome Score, 5th subscale (KOOS5) as a Measure of Treatment Efficacy

KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Each subscale is meant to be scored separately. In this protocol, the 5th subscale (KOOS5) will be used, which measures knee-related quality of life.
Screen, Month 3, Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucas R. Cusumano, MD

Investigators

  • Principal Investigator: Lucas Cusumano, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 21, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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