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

NCT02753101 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 32231
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome; Sciatica

Keywords

Positron Emission Tomography; Magnetic Resonance Imaging; PET/MRI; sigma-1 receptor; radiopharmaceutical; complex regional pain syndrome; sciatica; chronic pain

Outcome Measures

Primary Outcomes (1)

• Biodistribution of [18F]FTC-146

  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.

  an estimated average of 2 hours

Secondary Outcomes (2)

• Dosimetry of [18F]FTC-146

  an estimated average of 2 hours

• Incidence of Adverse Events

  Baseline and up to 7 days after tracer injection

Study Arms (1)

Single Arm

EXPERIMENTAL

\[18F\]-FTC-146

Drug: [18F]-FTC-146

Interventions

[18F]-FTC-146 DRUG

10 mCi± 1 mCi of \[18F\]FTC-146 intravenously

Also known as: Sigma-1 receptor radioligand

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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,
• Spinal, hip or pelvic surgery or prosthesis
• Cancer
• Radiation therapy

Sponsors & Collaborators

• Stanford University: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (6)

• James ML, Shen B, Nielsen CH, Behera D, Buckmaster CL, Mesangeau C, Zavaleta C, Vuppala PK, Jamalapuram S, Avery BA, Lyons DM, McCurdy CR, Biswal S, Gambhir SS, Chin FT. Evaluation of sigma-1 receptor radioligand 18F-FTC-146 in rats and squirrel monkeys using PET. J Nucl Med. 2014 Jan;55(1):147-53. doi: 10.2967/jnumed.113.120261. Epub 2013 Dec 12.

  PMID: 24337599 BACKGROUND

• James ML, Shen B, Zavaleta CL, Nielsen CH, Mesangeau C, Vuppala PK, Chan C, Avery BA, Fishback JA, Matsumoto RR, Gambhir SS, McCurdy CR, Chin FT. New positron emission tomography (PET) radioligand for imaging sigma-1 receptors in living subjects. J Med Chem. 2012 Oct 11;55(19):8272-8282. doi: 10.1021/jm300371c. Epub 2012 Sep 20.

  PMID: 22853801 BACKGROUND

• Fletcher JW, Djulbegovic B, Soares HP, Siegel BA, Lowe VJ, Lyman GH, Coleman RE, Wahl R, Paschold JC, Avril N, Einhorn LH, Suh WW, Samson D, Delbeke D, Gorman M, Shields AF. Recommendations on the use of 18F-FDG PET in oncology. J Nucl Med. 2008 Mar;49(3):480-508. doi: 10.2967/jnumed.107.047787. Epub 2008 Feb 20.

  PMID: 18287273 BACKGROUND

• Puente B, Nadal X, Portillo-Salido E, Sanchez-Arroyos R, Ovalle S, Palacios G, Muro A, Romero L, Entrena JM, Baeyens JM, Lopez-Garcia JA, Maldonado R, Zamanillo D, Vela JM. Sigma-1 receptors regulate activity-induced spinal sensitization and neuropathic pain after peripheral nerve injury. Pain. 2009 Oct;145(3):294-303. doi: 10.1016/j.pain.2009.05.013. Epub 2009 Jun 7.

  PMID: 19505761 BACKGROUND

• Entrena JM, Cobos EJ, Nieto FR, Cendan CM, Gris G, Del Pozo E, Zamanillo D, Baeyens JM. Sigma-1 receptors are essential for capsaicin-induced mechanical hypersensitivity: studies with selective sigma-1 ligands and sigma-1 knockout mice. Pain. 2009 Jun;143(3):252-261. doi: 10.1016/j.pain.2009.03.011. Epub 2009 Apr 17.

  PMID: 19375855 BACKGROUND

• Maurer AH. Combined imaging modalities: PET/CT and SPECT/CT. Health Phys. 2008 Nov;95(5):571-6. doi: 10.1097/01.HP.0000334064.46217.20.

  PMID: 18849691 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Sciatica; Chronic Pain

Interventions

6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandip Biswal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 27, 2016
• Study Start: February 9, 2016
• Primary Completion: February 9, 2017
• Study Completion: February 16, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)