FDG PET/MR Imaging of Peripheral Pain Generators in Persistent Post-Surgical Pain (PPSP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in SUVmax (chronic pain)
研究概览
简要总结
The purpose of this research is to determine if a PET/MRI scan using FDG can accurately identify the source of chronic pain. Identifying the source of pain may help doctors treat chronic pain more effectively. Approximately 128 participants will be enrolled and can expect to be on study for up to 12 months.
详细描述
The investigators aim to precisely localize sites of increased inflammation and potentially pain generation and improve understanding of nociception and inflammation using a unique, hybrid PET/MRI approach in conjunction with intravenously, administered fluorodeoxyglucose (FDG), which has been shown with PET imaging to be an sensitive surrogate marker of inflammation.
The Primary Objective of this pilot prospective, observational research is to determine whether this approach, which combines PET/MRI and an FDA-approved radiotracer, 18F-Fluorodeoxyglucose (FDG), can accurately localize the sites of painful inflammation in individuals with persistent pain.
- Determine if increased FDG uptake on PET as measured by standard uptake value (SUV) or target-to-background (TTB) measurements is increased in area of pain symptoms when compared to same corresponding areas in healthy, asymptomatic volunteers.
- Determine whether amount of FDG uptake as measured on PET is able to localize to abnormalities when compared to MR imaging (T2 signal intensity, morphologic aberrations)
Secondary Objectives:
- Verify that the standard administered adult dose of FDG (0.14 mCi/kg/patient) used currently in the clinics can also be used to detect peripheral pain generators.
- Verify that FDG uptake in asymptomatic, healthy controls will be significantly less than their chronic pain cohorts at the same anatomic location.
- Determine whether longitudinal FDG PET/MR imaging findings in individual patients directly correlate with symptoms as they evolve over time in joint arthroplasty subjects with PPSP.
- Determine if FDG PET/MR imaging findings spatially differ between different pain types.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persistent Post-Surgical Pain Patients
- •18-85 years old
- •Presents with persistent pain with pain score of ≥4 on Numerical Rating Scale [0:10] for at least 6 months following joint arthroplasty or arthroscopy.
- •Able and willing to provide informed consent
- •Willing and able to undergo PET/MRI (arthroplasty and arthroscopy participants) and PET/CT (arthroplasty participants only)
- •Inclusion Criteria: Asymptomatic controls
- •18-85 years old
- •Asymptomatic (pain score of ≤2 on the NRS) for at least 6 months following joint arthroplasty or arthroscopy.
- •Able and willing to provide informed consent
- •Willing and able to undergo PET/MRI
排除标准
- •Inability to understand and communicate with the investigators to complete the study-related questionnaires.
- •Any co-morbidity which results in severe systemic disease limiting function as defined by the American Society of Anesthesiology (ASA) physical status classification > 3, such as the presence of current or past (6 months) pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to chronic pain.
- •Pregnant or breastfeeding. (Individuals with childbearing potential will be asked to verbally confirm they are not pregnant. If they cannot confirm, they will have a urine pregnancy test either at the imaging study visit or within 7 days prior to the imaging study visit.)
- •Subject with contraindication(s) to or inability to undergo PET/MRI
- •Current diagnosis of malignancy of any kind. Participants in remission for at least two years and not undergoing any treatment may be considered per investigator discretion
- •Current enrollment in a scientific interventional or treatment study.
- •Subject unable or unwilling to provide informed consent
研究组 & 干预措施
Open Surgical Procedure (Arthroplasty)
PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement).
- 6 month post-op scans
- 12 month post-op scans
- 18 month post-op scans
干预措施: FDG radiotracer (Drug)
Open Surgical Procedure (Arthroplasty)
PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement).
- 6 month post-op scans
- 12 month post-op scans
- 18 month post-op scans
干预措施: PET/MRI (Device)
Open Surgical Procedure (Arthroplasty)
PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement).
- 6 month post-op scans
- 12 month post-op scans
- 18 month post-op scans
干预措施: PET/CT imaging (Device)
Less Invasive Procedure (Arthroscopy)
PPSP subjects who have undergone hip (or knee) arthroscopy (i.e., less invasive joint surgical procedure involving scopes and lower profile surgical tools)
- 6 month post-op scans
干预措施: FDG radiotracer (Drug)
Less Invasive Procedure (Arthroscopy)
PPSP subjects who have undergone hip (or knee) arthroscopy (i.e., less invasive joint surgical procedure involving scopes and lower profile surgical tools)
- 6 month post-op scans
干预措施: PET/MRI (Device)
Asymptomatic: Had Total Joint Replacement (Arthroplasty)
Asymptomatic subjects who have undergone total hip or total knee arthroplasty.
- single scan during one study visit (up to 3.5 hours)
干预措施: FDG radiotracer (Drug)
Asymptomatic: Had Total Joint Replacement (Arthroplasty)
Asymptomatic subjects who have undergone total hip or total knee arthroplasty.
- single scan during one study visit (up to 3.5 hours)
干预措施: PET/MRI (Device)
Asymptomatic: Less Invasive Procedure (Arthroscopy)
Asymptomatic subjects who have undergone hip or knee arthroscopy.
- single scan during one study visit (up to 3.5 hours)
干预措施: FDG radiotracer (Drug)
Asymptomatic: Less Invasive Procedure (Arthroscopy)
Asymptomatic subjects who have undergone hip or knee arthroscopy.
- single scan during one study visit (up to 3.5 hours)
干预措施: PET/MRI (Device)
结局指标
主要结局
Change in SUVmax (chronic pain)
时间窗: baseline (6 months post-op), 12 months post-op, 18 months post-op
SUVmax (chronic pain vs healthy)
时间窗: baseline
Location of Pain Compared to Target-to-Background (TTB) or SUVmax
时间窗: baseline
次要结局
- Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups)(baseline)
- Variation of the maximum ratio of SUV (SUVRmax) in asymptomatic controls vs symptomatic(baseline)
- Variation of the maximum ratio of SUV (SUVRmax) in symptomatic participants(baseline (6 months post-op), 12 months post-op, 18 months post-op)
- Change in Pain Scores (chronic pain)(baseline (6 months post-op), 12 months post-op, 18 months post-op)
- Radiology Review Scores(up to 18 months post-op)