FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: PFJ OA Patients
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, pre-loading
2

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.

Time frame
baseline, post-loading

Secondary outcomes

1

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.

Time frame
baseline
2

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.

Time frame
baseline

Other outcomes

Sponsors and contacts

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

University of California, San Francisco

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator