CLINICAL TRIALS

SUMMARY

We are developing and validating new imaging approaches to enable early and accurate detection of the molecular underpinnings of pain by helping develop novel PET radiotracers (also referred to as 'tracers' or 'probes' or 'radioligands') or repurposing FDA-approved radiotracers designed to specifically pinpoint pro-nociceptive pathology.  After injecting a tracer intravenously into a volunteer, the tracer will localize to parts of the body which are sending pain signals.  We then take a picture of where the tracer is located using a device called positron emission tomography/magnetc resonance imaging (PET/MRI).  The images that are generated will be evaluated by the clinical imaging scientists and the results will be discussed with the referring physician to come up with a plan to manage the patient's pain. 

Two clinical trials are available: Clinical Trial A and Clinical Trial B (please see below). 

 

Clinical Trial A, which is a Phase 1 study, utilizes a new experimental radiotracer that is theoretically more specific for tissues signaling pain.  Clinical Trial B makes use of an FDA-approved tracer that has been used for cancer detection for decades but is now has been repurposed for the detection of pain generators in this trial (off-label use).

**Please note that participation in this trial will expose the study subject to a relatively small dose of radiation- a dose similar to what is administered during a CT scan of the chest and abdomen.

Clinical Trial A:

Sigma-1 receptor radiotracer

Several studies have implicated involvement of sigma-1 receptors (S1Rs) in the generation of chronic pain, while others are investigating anti S1R drugs for treatment of chronic pain. Using S1R radiotracer (also known as [18F]-FTC-146) and positron emission tomography/magnetic resonance imaging (PET/MRI), we aim to identify the source of pain generation in patients with chronic pain.  We expect that the location of S1R radiotracer in pain may provide a tool to diagnose pain generators, monitor treatment response, and aid in the selection of patients for treatment.

The goal is to use [18F]FTC-146 to image S1R expression in healthy volunteers and to compare the images to those individuals suffering from pain conditions in the following categories: (1) nociceptive pain (pain that results from tissue injury or inflammation), (2) neuropathic pain (pain that results from direct injury, disruption, impingement/compression or malfunction of the peripheral and/or central nervous system), and (3) mixed pain (pain that appears to have both nociceptive and neuropathic).

Please scroll down below for Inclusion and Exclusion criteria. 

**Please note that participation in this trial will expose the study subject to a relatively small dose of radiation- a dose similar to what is administered during a CT scan of the chest and abdomen.

Please click here for clinicaltrails.gov site for more details.

ClinicalTrials.gov Identifier: NCT03556137

Clinical Trial B:

Fluorodeoxyglucose radiotracer

Evidence in the literature points strongly toward an active inflammatory component in chronic pain. For example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. Similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. It is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as [18F]fluorodeoxyglucose ([18F]FDG).

 

Correspondingly, [18F]FDG positron emission tomography-magnetic resonance imaging (PET/MRI) represent leading FDA-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. One of the goals of the study is to determine whether [18F]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.

Please scroll down below for Inclusion and Exclusion criteria. 

**Please note that participation in this trial will expose the study subject to a relatively small dose of radiation- a dose similar to what is administered during a CT scan of the chest and abdomen.

Please click here for clinicaltrails.gov site for more details.

ClinicalTrials.gov Identifier: NCT03195270

Inclusion and Exclusion Criteria

Inclusion Criteria:

  • Age 18 years or older.

  • Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine.

  • Provides informed consent

  • On a typical day, pain level of at least 4/10 on a 0-10 Comparative Pain Scale

Exclusion Criteria:

  • MRI-incompatible.

  • Diabetes.

  • Pregnant or nursing.

  • Non-English speaker.

Procedure Description 

Participants will be recruited based on established criteria given above for chronic pain. Depending on which medications are being taken, a study subject may be asked to stop their pain medications 2-3 days before the scan only if the patient is able to tolerate the stoppage of medication,

 

For the PET/MRI scan, the participants will be injected with 10 mCi±1 mCi of previously decided radiotracer (either the sigma-1 receptor radioligand or [18F]FDG) via the antecubital vein in a bolus injection. PET and MRI scans will be acquired simultaneously using a hybrid PET/MRI scanner. The scan will occur over a period of 60 to 90 minutes. There may be a break at approximately 30 minutes into the scan. 

 

Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report. The biodistribution of radiotracer will be analyzed using regions of interest (ROI) marked on anatomical structures on magnetic resonance images and quantifying the signal in PET images within the same ROIs. Pharmacokinetic information will be derived using mathematical modeling. Data from chronic pain patients will be compared to historical data from asymptomatic controls.

THE BISWAL LAB

1201 Welch Rd.

Stanford, CA 94305

Email: biswal@stanford.edu

Tel: 650-725-8018

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Scanning Hours:

Mon - Fri: 8am - 8pm 

​​Saturday: Closed ​

Sunday: Closed

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© 2020 by Sandip Biswal.