Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-12-04
Brief Title:
FDG PETMR Imaging of Peripheral Pain Generators
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
FDG PETMR Imaging of Peripheral Pain Generators in Persistent Post-Surgical Pain PPSP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 PETMRI 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 PETMRI 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 PETMRI 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 014 mCikgpatient 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 PETMR imaging findings in individual patients directly correlate with symptoms as they evolve over time in joint arthroplasty subjects with PPSP
Determine if FDG PETMR 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 PETMRI 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 014 mCikgpatient 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 PETMR imaging findings in individual patients directly correlate with symptoms as they evolve over time in joint arthroplasty subjects with PPSP
Determine if FDG PETMR imaging findings spatially differ between different pain types
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR077706 | NIH | None | None |
| SMPHRADIOLOGYRADIOLOGY | OTHER | None | None |
| Protocol Version 5222024 | OTHER | UW Madison | httpsreporternihgovquickSearchR01AR077706 |