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Recruiting

NCT Number: NCT07807943

Prospective Observational Study Of Geniculate Artery Embolization For Symptomatic Knee Osteoarthritis In A Cancer Population

To explore associations with demographics/clinical factors; assess trajectories via annual follow-up; evaluate healthcare utilization and barriers; oversample >10-year survivors.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77044, United States

Location status: Recruiting

Location contact

Cardenas J Nicolas, MD

PRINCIPAL_INVESTIGATOR

Nicolas J Cardenas, MD

CONTACT

[email protected]

713-794-4404

About this study

Primary Objective To characterize the change in knee pain and functional disability following standard-of-care GAE in cancer participants with symptomatic knee osteoarthritis, as measured by mean change in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to 12 months

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥40 years with no upper age restriction, provided performance status permits procedural candidacy
  • Symptomatic mild-to-severe knee osteoarthritis (Kellgren-Lawrence grade 2-4) on radiographs within 6 months of enrollment
  • Chronic knee pain (NRS ≥4/10) for ≥3 months despite conservative treatment including steroid injections, physical therapy, and/or analgesic medications
  • Inadequate candidate for or refusal of surgical intervention (e.g., total knee arthroplasty) due to cancer-related comorbidities, ongoing treatment, or participants preference
  • Active cancer diagnosis (solid tumor or hematologic malignancy) confirmed at MD Anderson Cancer Center

Exclusion criteria

  • Active joint infection or suspected septic arthritis
  • Life expectancy <6 months
  • Prior knee arthroplasty in the index knee
  • Coagulopathy or contraindications to angiography
  • GFR <30 mL/min/1.73m²
  • Peripheral artery disease with stenosis or occlusion of lower extremity vasculature (relative contraindication per SIR standards, given geniculate artery collateral perfusion role)
  • Radiographically normal knee joint (KL grade 0-1) - alternative etiologies should be sought
  • Known active autoimmune/inflammatory arthropathy (e.g., rheumatoid arthritis, psoriatic arthritis)
  • Any medical condition or clinical abnormality that, per investigator judgment, precludes safe participation in and completion of the study

Treatment and study plan

SOC (Standard of care)

Other

Patients scheduled for standard of care

Primary outcomes

  1. Numeric Rating Scale Questionnaire

    Time frame: Through study completion; an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas J Cardenas, MD

CONTACT

[email protected]

713-794-4404

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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