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IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

ConditionsKnee OsteoarthritisKnee DiscomfortKnee Pain ChronicKnee Swelling Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorLucas R. Cusumano, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Embolization

    Device

    Genicular artery embolization

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TreatmentOther 1 intervention

Trial outcomes

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).

Time frame
Screening, Month 6

Secondary outcomes

1

Associate changes in metabolic activity detected by PET

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).

Time frame
Screening, Month 6
2

Assess osseous metabolic abnormalities correlation with osseous abnormalities and cartilage degeneration

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.

Time frame
Screening, Month 6
3

Safety of GAE

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

Time frame
Treatment, Month 3, Month 6, Month 12
4

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

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.

Time frame
Screen, Month 3, Month 6, Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lucas R. Cusumano, MD

Lead sponsor

University of California, Los Angeles

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: