About this trial
This project aims to develop an \[18F\] fluorodeoxyglucose (FDG) positron emission tomography (PET) / magnetic resonance imaging (MRI) method to locate the painful inflammation in PFJ OA associated with joint loading. \[18F\] FDG PET/MRI is an emerging pain imaging approach with enhanced sensitivity to painful hypermetabolic inflammation through evaluation of intracellular glucose utilization rate via (\[18F\]FDG PET) and fine anatomy details (MRI). The investigative group has shown its promise in revealing previously unidentified or unspecified pain generators in various musculoskeletal pain conditions. The investigators have also demonstrated the feasibility of visualizing the structural changes between unloaded and loaded knee joints with MRI, which can be easily adopted in the current PET/MRI setting. The main challenge in the proposed \[18F\]FDG PET/MRI approach is to differentiate the normal uptake of FDG for metabolic changes by weight-bearing from abnormal changes indicating eventual pain aggravation by weight-bearing and knee-flexion. The investigators have garnered the following two aims to validate the proposed method by comparing unloaded and loaded knee imaging results between PFJ OA pain patients and asymptomatic, matched controls.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult with the capacity to give informed consent
Ability to perform 25 single-leg squats
No traumatic knee injuries/surgeries since last visit for the parent study (IRB #21-34763)
No investigational drugs since last visit for the parent study (IRB #21-34763)
Disqualifiers
Inability to consent for themselves
Inability to perform 25 single-leg squats with the study leg
New traumatic knee injuries/surgeries since last visit for the parent study (IRB #21-34763)
Taking investigational drugs since last visit for the parent study (IRB #21-34763)
Trial population
The study population includes outpatient individuals with patellofemoral joint osteoarthritis (PFJ OA) and healthy asymptomatic volunteers recruited from the University of California, San Francisco (UCSF) and the surrounding community
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Maximum Standardized Uptake Value (SUVmax) of [18F]FDG in PFJ Tissues, Pre-Loading
Comparison of FDG SUVmax between PFJ OA patients and asymptomatic controls across various tissue types (synovium, femur, tibia, meniscus, fat pad, and muscles) to identify hypermetabolic inflammation at pre-loading.
Maximum Standardized Uptake Value (SUVmax) of [18F]FDG in PFJ Tissues, Post-Loading
Comparison of FDG SUVmax between PFJ OA patients and asymptomatic controls across various tissue types (synovium, femur, tibia, meniscus, fat pad, and muscles) to identify hypermetabolic inflammation at post-loading.
Secondary outcomes
Change in SUVmax Between Unloaded and Loaded States
The difference in FDG SUVmax measurements between the loaded PFJ and the unloaded PFJ imaging sessions to determine sensitivity to loading-induced inflammation.
Visual Analog Scale Maximum Pain Score During a Single-Leg Squat
Assessment of maximum pain levels during a single-leg squat. Pain will be evaluated using a Visual Analog Scale, where scores range from 0 to 10, with 0 indicating "no pain" and 10 indicating "worst possible pain". Higher scores represent a worse outcome. Individual scores will be analyzed in relation to FDG uptake and loaded-unloaded uptake differences.
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator