UW School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Location status: Recruiting
NCT Number: NCT06171659
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Madison, Wisconsin, 53792, United States
Location status: Recruiting
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.
Secondary Objectives:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Persistent Post-Surgical Pain Patients
Inclusion criteria
Asymptomatic controls
Exclusion criteria
Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[18F]fluoro-D-g1ucose, which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection. Dosage planned 0.14 mCi/kg/patient.
Other names: fluorodeoxyglucose, 18F-Fluorodeoxyglucose
positron emission tomography and magnetic resonance imaging
positron emission tomography and computed tomography imaging
Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op
Time frame: baseline
Time frame: baseline
Time frame: baseline
The standard administered adult dose of FDG currently used in clinics is 0.14 mCi/kg/patient.
Time frame: baseline
Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op
Time frame: up to 18 months post-op
Radiologists will evaluate MRI and CT images from each exam, and assign 1 point to any abnormality detected in the following compartments: prosthesis itself, bone, joint space, joint capsule, muscle, subcutaneous fat, and skin, for a total of 7 possible points. Differences in scoring from MRI vs CT images will be further investigated with a t-test.
Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op
Pain will be evaluated on a scale of 0 (no pain) to 10 (worse possible pain).
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
FDG PET/MR Imaging of Peripheral Pain Generators in Persistent Post-Surgical Pain (PPSP)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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