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Not yet recruiting NCT07494838

IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

No phase Interventional Knee Osteoarthritis Knee Discomfort Knee Pain Chronic Knee Swelling Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embolization.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Knee Discomfort, Knee Pain Chronic, Knee Swelling Pain. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Embolization
    Genicular artery embolization

Primary outcome measures

  • Compare metabolic activity [Time frame: Screening, Month 6]
Secondary outcome measures (6)
  • Associate changes in metabolic activity detected by PET [Time frame: Screening, Month 6]
  • Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration [Time frame: Screening, Month 6]
  • Safety of GAE [Time frame: 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]
  • Change From Baseline in Visual Analog Scale (VAS) as a Measure of Treatment Efficacy [Time frame: Screen, Month 3, Month 6, Month 12]
  • Assess KOOS5 [Time frame: Screen, Month 3, Month 6, Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Publications

  • Akira S, Takeda K. Toll-like receptor signalling. Nat Rev Immunol. 2004 Jul;4(7):499-511. doi: 10.1038/nri1391. No abstract available. PMID 15229469
  • Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15. PMID 21081524
  • Bagla S, Piechowiak R, Hartman T, Orlando J, Del Gaizo D, Isaacson A. Genicular Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2020 Jul;31(7):1096-1102. doi: 10.1016/j.jvir.2019.09.018. Epub 2019 Dec 16. PMID 31837946
  • Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2. PMID 34610422
  • Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27. PMID 23194896
  • Bonomo G, Pedicini V, Monfardini L, Della Vigna P, Poretti D, Orgera G, Orsi F. Bland embolization in patients with unresectable hepatocellular carcinoma using precise, tightly size-calibrated, anti-inflammatory microparticles: first clinical experience and one-year follow-up. Cardiovasc Intervent Radiol. 2010 Jun;33(3):552-9. doi: 10.1007/s00270-009-9752-y. Epub 2009 Dec 3. PMID 19957182
  • Chan WP, Lang P, Stevens MP, Sack K, Majumdar S, Stoller DW, Basch C, Genant HK. Osteoarthritis of the knee: comparison of radiography, CT, and MR imaging to assess extent and severity. AJR Am J Roentgenol. 1991 Oct;157(4):799-806. doi: 10.2214/ajr.157.4.1892040. PMID 1892040
  • Chandran V, Abji F, Perruccio AV, Gandhi R, Li S, Cook RJ, Gladman DD. Serum-based soluble markers differentiate psoriatic arthritis from osteoarthritis. Ann Rheum Dis. 2019 Jun;78(6):796-801. doi: 10.1136/annrheumdis-2018-214737. Epub 2019 Mar 25. PMID 30910989

Identifiers

NCT: NCT07494838 · 25-2531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗