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[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS and Sciatica

NCT02753101 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-03-05

No results posted yet for this study

Summary

Chronic pain can result from injured or inflamed nerves, as occurs in people suffering from sciatica and CRPS. These nerve injuries or regions of nerve irritation are often the cause of pain in these conditions, but the current diagnostic tools are limited in pinpointing the area of origin. Several studies have implicated involvement of sigma-1 receptors in the generation and perpetuation of chronic pain conditions, others are investigating anti sigma-1 receptor drugs for the treatment of chronic pain. Using the sigma-1 receptor (S1R) detector and experimental radiotracer \[18F\]FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI) scanner, the researchers may potentially identify the source of pain generation in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica. The ultimate goal is to assist in the optimization of pain treatment regimens using an \[18F\]FTC-146 PET/MRI scan.

The study is not designed to induce any physiological/pharmacological effect.

Conditions

  • Complex Regional Pain Syndrome
  • Sciatica

Interventions

DRUG

[18F]-FTC-146

10 mCi± 1 mCi of \[18F\]FTC-146 intravenously

Sponsors & Collaborators

Principal Investigators

  • Sandip Biswal, MD · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-09
Primary Completion
2017-02-09
Completion
2017-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753101 on ClinicalTrials.gov