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

2026년 6월 1일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • California
      • San Francisco, California, 미국, 94107
        • 모병
        • UCSF Radiology China Basin
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

해당 없음

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum Standardized Uptake Value (SUVmax) of [18F]FDG in PFJ Tissues, Pre-Loading
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in SUVmax Between Unloaded and Loaded States
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Richard Souza, PhD, PT, University of California, San Francisco

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 19일

기본 완료 (추정된)

2028년 2월 1일

연구 완료 (추정된)

2028년 2월 1일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • K24AR072133 (미국 NIH 보조금/계약)
  • 24-41266 (기타 식별자: UCSF IRB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다