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FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis (FDG-PFJOA)

1 de junio de 2026 actualizado por: University of California, San Francisco

Understanding Painful Inflammation in Patellofemoral Joint OA Using [18F] FDG

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.

Descripción general del estudio

Descripción detallada

Background:

Imaging of pain from patellofemoral joint osteoarthritis (PFJ OA): PFJ OA is primarily defined as the degeneration of the cartilage of the PFJ; however, the cartilage itself is not innervated and thus cannot be a source of pain. The knee joint is composed of a variety of other innervated tissues, including the synovium, subchondral bone, meniscus, ligaments, tendons, muscles, and infrapatellar fat pad. The degeneration of the patella cartilage may result from or even result in some form of damage to these innervated joint tissues, which eventually leads to the sensation of pain. The main challenge in imaging identification of pain generators in PFJ OA is that structural abnormalities that can cause pain also frequently occur in the asymptomatic population as a natural wear-and-tear process with aging. For example, meniscal tears on MRI are nearly equally prevalent (~60%) in symptomatic and asymptomatic knees. The proposed approach here is to adopt [18F]FDG PET/MRI, a molecular imaging technique highly sensitive to hypermetabolic inflammation. Pain in PFJ OA may stem from inflammatory responses to tissue damage, leading to the increased activities of immune cells causing the local surge of need for energy. [18F]FDG PET is the most widely accepted imaging modality for identifying pathology by visualizing hotspots of energy demand and has recently shown strong promise in detecting painful hypermetabolic inflammation in multiple musculoskeletal pain conditions. Therefore, the proposed implementation of [18F]FDG PET/MRI for PFJ OA will facilitate pinpointing hypermetabolic pain generators that conventional structural imaging techniques have failed to identify.

Loading of PFJ OA: The magnitude and distribution of loads across a joint have the potential to accelerate structural OA decline and result in pain. While biomechanical factors are known to influence the progression of TFJ OA, little is known about the role of biomechanical factors in PFJOA disease progression. These factors are likely to differ from those for TFJ OA progression as a result of the unique functions and design of the different joints. The investigative team has extensive experience in the field of biomechanics and OA. Elevated PFJ stress during squatting was demonstrated in people with patellofemoral pain, a condition affecting younger adults with similar features to PFJ OA. Preliminary work by the investigators confirmed higher PFJ stress during walking in individuals with PFJ OA compared to controls. These data suggest that elevated PFJ stress is likely a contributory factor in PFJ OA. Increased knee extensor moments can result in higher PFJ reaction forces and PFJ stress at a given knee angle and thus may be a potential risk factor for PFJ OA progression. Preliminary work by the investigators showed that higher knee extensor moment during late stance was predictive of structural progression of PFJ OA at one-year follow-up. The current supplement will support further investigation in single-leg squat biomechanics in persons with painful PFJ OA and asymptomatic matched controls. These data are necessary to understand the impact of loading and squat kinematics on pain, leading to novel movement-based interventions for pain management.

AIMS:

Aim 1: Identification of painful inflammation in the unloaded knee with PFJ OA The investigators will 1) compare [18F]FDG uptake measurements of the unloaded knee between symptomatic PFJ OA knees and asymptomatic knees and 2) analyze the correlation between [18F]FDG and biomechanical measurements. The investigators will recruit 25 PFJ OA patients with pain reproducible with a weight-bearing exercise (single-leg squats) and 25 age/sex/BMI-matched asymptomatic controls. The [18F]FDG PET/MRI session of the unloaded knee will yield the max measurements of [18F]FDG standardized uptake value (SUV) in the local hotspots. All subjects will have a post-imaging functional assessment through a battery of physical performance tests for biomechanical measurements. The investigators will compare the [18F]FDG uptake measurements between patients and controls using the t-test and conduct a generalized linear model (GLM) analysis to determine the biomechanical measurements predicting the [18F]FDG uptake measurements.

Aim 2: Identification of painful inflammation in the loaded knee with PFJ OA The investigators will identify abnormal [18F]FDG hotspots in the PFJ of the patients due to knee loading by comparison with asymptomatic controls. After the [18F]FDG PET/MRI session in Aim 1, the participant will be re-scanned using the same PET/MRI protocol while loading the knee continuously with 25% bodyweight using a custom-made device. The investigators will measure the difference of the [18F]FDG SUVmax between the unloaded and loaded sessions in the synovium, femur, tibia, meniscus, fat pad, and muscle around the PFJ. [18F]FDG uptake difference will be compared between PFJ OA patients and asymptomatic controls using the t-test and GLM analysis to determine biomechanical measurements prediction of [18F]FDG uptake difference.

The successful execution of the proposed aims will offer a novel, non-invasive imaging method to identify the painful inflammation in PFJ OA as well as increased inflammatory response due to joint loading, which will eventually aggravate the pain. Together with the ongoing development in the parent R01 project to visualize bone remodeling and cartilage compositional changes, this project will facilitate building a comprehensive imaging method to examine the underlying degenerative process and the symptomatic manifestation of PFJ OA.

Tipo de estudio

De observación

Inscripción (Estimado)

50

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • California
      • San Francisco, California, Estados Unidos, 94107
        • Reclutamiento
        • UCSF Radiology China Basin
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

Inclusion Criteria:

  • 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)
  • No contraindications to MRI or PET tracer since last visit for the parent study (IRB #21-34763)
  • Not taking steroid injections
  • Not pregnant
  • Additional inclusion criteria for healthy volunteers: Minimal pain (VAS=0-1) during a series of 25 single-leg squats on one or both legs

Exclusion Criteria:

  • 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)
  • New contraindications to MRI or PET tracer since last visit for the parent study (IRB #21-34763)
  • Taking steroid injections
  • Pregnant
  • Diabetic
  • Additional exclusion criteria for healthy volunteers: VAS of 2 or greater during a series of 25 single-leg squats on both legs

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
PFJ OA Patients
Group defined as WORMS 2-6, and >1 VAS pain during 25 single-leg squats
Healthy Controls
Healthy volunteers with WORMS 0-1, and 0-1 VAS pain during 25 single-leg squats

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximum Standardized Uptake Value (SUVmax) of [18F]FDG in PFJ Tissues, Pre-Loading
Periodo de tiempo: baseline, 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.
baseline, pre-loading
Maximum Standardized Uptake Value (SUVmax) of [18F]FDG in PFJ Tissues, Post-Loading
Periodo de tiempo: baseline, 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.
baseline, post-loading

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in SUVmax Between Unloaded and Loaded States
Periodo de tiempo: baseline
The difference in FDG SUVmax measurements between the loaded PFJ and the unloaded PFJ imaging sessions to determine sensitivity to loading-induced inflammation.
baseline
Visual Analog Scale Maximum Pain Score During a Single-Leg Squat
Periodo de tiempo: baseline
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.
baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Richard Souza, PhD, PT, University of California, San Francisco

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de febrero de 2025

Finalización primaria (Estimado)

1 de febrero de 2028

Finalización del estudio (Estimado)

1 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • K24AR072133 (Subvención/contrato del NIH de EE. UU.)
  • 24-41266 (Otro identificador: UCSF IRB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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