Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06171659
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FDG PET/MR Imaging of Peripheral Pain Generators
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
FDG PET/MR Imaging of Peripheral Pain Generators in Persistent Post-Surgical Pain (PPSP)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AR077706 | NIH | None | https://reporter.nih.gov/quic… | View |
| SMPH/RADIOLOGY/RADIOLOGY | OTHER | UW Madison | View | |
| Protocol Version 11/1/2024 | OTHER | UW Madison | View |