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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Treatment with GAE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization | Device | Genicular artery embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Screening, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arshia Mian, BS | Contact | 310-906-6028 | ammian@mednet.ucla.edu | |
| Lucas Cusumano, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Lucas Cusumano, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15229469 | Background | Akira S, Takeda K. Toll-like receptor signalling. Nat Rev Immunol. 2004 Jul;4(7):499-511. doi: 10.1038/nri1391. No abstract available. | |
| 21081524 | Background | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| 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. |
| Screening, Month 6 |
| 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 | 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 | 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 | 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 | 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 |
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| D012216 |
| Rheumatic Diseases |