PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain with Spinal or Peripheral Nerve Origin.
Primary Objectives:
A) To quantify the bio-distribution of \[18F\] FTC-146 uptake in subjects with Spinal or Peripheral Nerve Origin pain and compare it with healthy controls.
B) To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging.
Secondary Objectives:
A) To assess the reproducibility of \[18F\]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis.
B) To investigate whether post-treatment \[18F\]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Volunteers
Pain Subjects
At least 18 years old.
Chronic Pain is of Spinal or Peripheral Nerve Origin
Disqualifiers
Healthy Volunteers
Any chronic Pain
Use of pain medication.
MRI incompatibility.
Trial design
Design model
Parallel
Treatments tested in this trial
[18F]FTC-146
DrugAdult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Pain Patients With Spinal or Peripheral Nerve OriginExperimental treatment 1 intervention
Group B: Healthy VolunteersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biodistribution of [18F]FTC-146- correlate with reported pain
Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level
Time frame
Estimated average of 4 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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