Health TrialsbyHealthPanel

FDG PET/MR Imaging of Peripheral Pain Generators

ConditionsPainNociceptive Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Participants with persistent post-surgical pain and asymptomatic individuals who have undergone joint arthroplasty (hip or knee) or joint arthroscopy (hip or knee).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • FDG radiotracer

    Drug

    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.

  • PET/MRI

    Device

    positron emission tomography and magnetic resonance imaging

  • PET/CT imaging

    Device

    positron emission tomography and computed tomography imaging

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Open Surgical Procedure (Arthroplasty)3 interventions
Group B: Less Invasive Procedure (Arthroscopy)2 interventions
Group C: Asymptomatic: Had Total Joint Replacement (Arthroplasty)2 interventions
Group D: Asymptomatic: Less Invasive Procedure (Arthroscopy)2 interventions

Trial outcomes

Primary outcomes

1

Change in SUVmax (chronic pain)

Time frame
baseline (6 months post-op), 12 months post-op, 18 months post-op
2

SUVmax (chronic pain vs healthy)

Time frame
baseline
3

Location of Pain Compared to Target-to-Background (TTB) or SUVmax

Time frame
baseline

Secondary outcomes

1

Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups)

The standard administered adult dose of FDG currently used in clinics is 0.14 mCi/kg/patient.

Time frame
baseline
2

Variation of the maximum ratio of SUV (SUVRmax) in asymptomatic controls vs symptomatic

Time frame
baseline
3

Variation of the maximum ratio of SUV (SUVRmax) in symptomatic participants

Time frame
baseline (6 months post-op), 12 months post-op, 18 months post-op
4

Radiology Review Scores

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
up to 18 months post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Arthroscopy Association of North America

Collaborator

Source ClinicalTrials.gov
Apply now