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

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ClinicalTrials.gov Identifier: NCT02753101
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Sandip Biswal, Stanford University

Brief 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.


Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Sciatica Drug: [18F]-FTC-146 Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Single Arm
[18F]-FTC-146
Drug: [18F]-FTC-146
10 mCi± 1 mCi of [18F]FTC-146 intravenously
Other Name: Sigma-1 receptor radioligand




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 criteria can be met OR individuals who have been determined to have a very high clinical suspicion of having CRPS as determined by the referring pain specialist can be included. This suspicion will be documented in the patient's medical record.

Exclusion Criteria:

General:

  • Another active disorder which could explain the symptoms in the opinions of the investigator
  • Failure to give informed consent
  • Presence of MRI-incompatible materials/devices
  • Any medication that may affect pain or 18F-FTC-146 uptake or adverse drug interactions with steroids or amino amide local anesthetics (e.g. lidocaine, bupivacaine, ropivacaine)
  • Pregnant or nursing
  • Ongoing menstrual period
  • Severe comorbid conditions
  • Unable to read or complete questionnaires in English
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study

Sciatica:

  • Any condition that may interfere with interpretation of 18F-FTC-146 uptake in the region of the pelvis, thighs or lower spine including, but not limited to,

    1. Spinal, hip or pelvic surgery or prosthesis
    2. Cancer
    3. Radiation therapy
    4. Autoimmune disorders
    5. Current infections
    6. Inability to void bladder completely, such as in prostatic enlargement
    7. Any urinary retention, such as in outlet obstruction, hydronephrosis etc.
    8. Cauda equina syndrome
    9. Developmental spinal deformities
    10. Scoliosis >20 degrees
    11. Spondylolysis
    12. Vertebral fractures
    13. Inflammatory spondylopathy
    14. Prior lumbar surgery

      CRPS:

  • Presence of current or past pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to CRPS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753101


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Mississippi Medical Center
Investigators
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Principal Investigator: Sandip Biswal, MD Stanford University

Publications:

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Responsible Party: Sandip Biswal, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02753101     History of Changes
Other Study ID Numbers: 32231
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandip Biswal, Stanford University:
Positron Emission Tomography
Magnetic Resonance Imaging
PET/MRI
sigma-1 receptor
radiopharmaceutical
complex regional pain syndrome
sciatica
chronic pain

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Sciatica
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action