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

Chronic pain can result from injured or inflamed nerves, as happens 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 have proven quite limited in pinpointing these areas. Several studies have implicated involvement of sigma-1 receptors in the generation and perpetuation of chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for the treatment of chronic pain. Using [18F]FTC-146, a sigma-1 receptor (S1R) detector and experimental radiotracer, and positron emission tomography/magnetic resonance imaging (PET/MRI), we hope to learn the best approach to identifying the site of nerve injury/inflammation (or other tissue injury/inflammation) as they related to painful conditions, and, therefore, help identify the source of pain generation. We will characterizing the disease in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica, with the overarching goal of optimizing or developing improved pain treatment regimens. The broad objectives of this study are: - To determine the dosimetry of [18F]FTC-146 - To evaluate the safety of [18F]FTC-146 after a single administration - To evaluate the pharmacokinetics and ability of the radiotracer to reflect S1R expression in healthy subjects and specific patient subpopulations . The study is not designed to induce any physiological/pharmacological effect.

  • This is a clinical trial. i
  • This is a clinical trial.i
  • This is a Early Phase 1 study. i
  • This study is enrolling both males and females.
  • This study is enrolling patients with age above 18 years .
  • This study is enrolling patients with any of the following conditions:
  • Complex Regional Pain Syndromes
  • Reflex Sympathetic Dystrophy
  • Sciatica

Who can participate in the study?

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)

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.

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

- Diagnosed psychiatric disorder

- 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

- Patients receiving worker's compensation

- 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.

Other Information

Sponsors:

Stanford University

Collaborator:
Responsible Party:

Sandip Biswal

Detailed Description:

Participants are either pain free or will be recruited based on established criteria for sciatica or CRPS. Patients outside the of age range (< 18 years), and those with contraindications for MRI or PET scanning will be excluded. A signed consent will be obtained from willing participants. For the PET/MRI scan, the participants will be injected with 10 mCi ± 1 mCi of [18F]FTC-146 via the antecubital vein in a bolus injection. For evaluation of plasmatic kinetics, blood samples will be taken from a subset of recruited subjects over 2 hours after injection of radiotracer to estimate plasma activity using a gamma counter. After injection, PET and MRI scans will be acquired simultaneously 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. For a subset of patients, small blood samples (2 teaspoons) for blood chemistry and hematology will be collected on the day of scanning and at follow-up visits at 24 hours and 1 week after injection. 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.

Start Date:

February 2016

Estimated Completion Date:

February 2021

Contact Locations

Stanford University
Stanford
California
United States
94305
Tel: 650-725-8018
Email: biswal@stanford.edu