[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS and Sciatica
|ClinicalTrials.gov Identifier: NCT02753101|
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : March 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndrome Sciatica||Drug: [18F]-FTC-146||Early Phase 1|
Participants are either pain free (control) or will be recruited based on established criteria for sciatica or CRPS. A signed consent will be obtained from willing participants.
For the PET/MRI scan, the participants will be injected with [18F]FTC-146 intravenously. After injection, simultaneous PET and MRI scans will be acquired using a hybrid PET/MRI scanner. Throughout scanning, participants will be monitored for blood pressure, temperature, heart rate and pulse oximetry. Participants will be asked to void their bladder as frequently as they can to reduce radiation exposure. Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report.
Evidence in the literature points strongly toward an involvement of S1 receptors in nervous system inflammation, which is known to be an important biologic disease/disorder mechanism for maintenance and perpetuation of chronic pain.
The main purpose of this research study is to image and identify activated pain pathways in human subjects using [18F]FTC-146 PET/MRI.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 9, 2016|
|Actual Primary Completion Date :||February 9, 2017|
|Actual Study Completion Date :||February 16, 2017|
Experimental: Single Arm
10 mCi± 1 mCi of [18F]FTC-146 intravenously
Other Name: Sigma-1 receptor radioligand
- Biodistribution of [18F]FTC-146 [ Time Frame: an estimated average of 2 hours ]
Biodistribution of [18F]FTC-146 will be analyzed by drawing regions of interest (ROI) for the reported organs on the PET/MRI images. Processing software will quantify the amount of [18F]FTC-146 uptake within the ROI's and display the amount in terms of standardized uptake values (SUV's).
Biodistribution data will be obtained by drawing regions of interest (ROI's) around organs on the PET/MRI images. Processing software will quantify the amount of [18F]FTC-146 uptake within the ROI's and display the amount in terms of standardized uptake values (SUV's).
Pharmacokinetic data will be calculated using kinetic analysis (mathematical modeling) of [18F]FTC-146 clearance from the blood.
- Dosimetry of [18F]FTC-146 [ Time Frame: an estimated average of 2 hours ]Dosimetry calculations will be determined using the biodistribution (reported as a primary outcome measure) and pharmacokinetics of the tracer in human organs.
- Incidence of Adverse Events [ Time Frame: Baseline and up to 7 days after tracer injection ][18F]FTC-146 Single IV Treatment-Emergent Adverse Events will be established by collectively assessing real-time vitals monitoring during scans, serial clinical lab work (i.e. blood tests), and patient symptomatic report at baseline and up to 7 days post-injection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753101
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Sandip Biswal, MD||Stanford University|