[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS and Sciatica
CompletedEarly phase 1NCT02753101
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Biodistribution and Pharmacokinetic Determination of the PET Radiopharmaceutical [18F]FTC-146 Using PET/MRI in Healthy (Asymptomatic) Volunteers and in Patients With CRPS and Sciatica
- Conditions
- Interventions
- Drug: [18F]-FTC-146
- Sponsor
- Stanford University
- Collaborators
- University of Mississippi Medical Center
- Start date
- 2016-02-09
- Primary completion
- 2017-02-09
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: General: * At least 18 years of age * Either male or female Sciatica: * History of pain shooting down a leg below the knee, to the foot or toes * Visual analog scale (VAS) at enrollment of \>4 with leg pain greater in intensity than the back pain * Focal disc herniation on MRI correlating with radicular symptoms defined as pain or paresthesias into the leg. * Examination with correlating radicular signs defined as any of the following: * pain reproduction with straight-leg-raising (pain shooting down the leg with less than 60 degrees elevation) * radicular pattern sensory changes (such as numbness or paresthesias) in the same area as pain * signs of radiculopathy (weakened hallux extension and/or Achilles tendon reflex) * The above inclusion criteria can be met OR individuals who have been determined to have a very high clinical suspicion of having Sciatica as determined by the referring pain specialist can be included. This suspicion will be documented in the patient's medical record. CRPS: * Disease duration of 6 months or longer * Continuing pain, which is disproportionate to any inciting event * Must report at least one symptom in three of the four following categories: 1. Sensory: Reports of hyperesthesia and/or allodynia 2. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry 3. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry 4. Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin) * Must display at least one sign at time of evaluation In two or more of the following categories: 1. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or temperature sensation and/or deep somatic pressure and/or joint movement) 2. Vasomotor: Evidence of temperature asymmetry ( \>1°C) and/or skin color changes and/or asymmetry 3. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry 4. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin) * There is no other diagnosis that better explains the signs and symptoms * For research purposes, diagnostic decision rule will be at least one symptom in all four symptom categories and at least one sign (observed at evaluation) in two or more sign categories. * The above inclusion crite…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02753101