Recruiting

GAE

Sponsor:

Lucas R. Cusumano, MD

Code:

NCT07494838

Conditions

Knee Osteoarthritis

Knee Discomfort

Knee Pain Chronic

Knee Swelling Pain

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Embolization

Study Details

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 Osteoarthritis

Knee Discomfort

Knee Pain Chronic

Knee Swelling Pain

Study ID

NCT07494838

Start date

Dec 30, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Treatment

Treatment with GAE

Interventions

Embolization

Genicular artery embolization

Primary outcome measure

  • Compare metabolic activity [ Time Frame: Screening, Month 6 ]

Central Contacts and Locations

Central contacts

Renato Escobar

310-956-6161raescobar@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rayne Shepard

(310) 562-9752rshepard@mednet.ucla.edu

Saima Chaabane, PhD

SChabaane@mednet.ucla.edu

More Information

Sponsor

Lucas R. Cusumano, MD

Last update posted

Nov 12, 2026

Last verified

Mar, 2026

Keywords

  • GAE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Lucas R. Cusumano, MD on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.