IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

N/ANot Yet RecruitingNCT07494838

Lucas R. Cusumano, MD25 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis Knee Discomfort Knee Pain Chronic Knee Swelling Pain

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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).

Time frame: 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.

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

IMAGES: Identifying Metabolic Imaging Association With Genicular Artery Embolization Success

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts