NCT03556137

Brief Summary

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using \[18F\]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6.5 years

First QC Date

June 2, 2018

Last Update Submit

July 18, 2023

Conditions

Neuropathic PainNociceptive PainMixed Pain (Nociceptive and Neuropathic)Spinal PainRadiculopathyMyelopathyNeurogenic Claudication

Keywords

PET/MRIChronic Pain

Outcome Measures

Primary Outcomes (2)

  • [18F]FTC-146 Biodistribution in Healthy Volunteers

    Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.

    Estimated average of 3 hours

  • [18F]FTC-146 Biodistribution in Pain Patients

    Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

    Estimated average of 3 hours

Study Arms (2)

Pain Patients

EXPERIMENTAL

Individuals suffering from nociceptive pain, neuropathic pain, and mixed pain (pain that appears to be both nociceptive and neuropathic) and undergo a \[18F\]FTC-146 PET/MRI scan.

Drug: [18F]FTC-146

Healthy Volunteers

EXPERIMENTAL

Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Drug: [18F]FTC-146

Interventions

[18F]FTC-146DRUG

Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.

Also known as: S1R
Healthy VolunteersPain Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers:
  • At least 18 years old.
  • Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.
  • Pain Patients:
  • At least 18 years old.
  • Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
  • Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
  • Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

You may not qualify if:

  • Healthy Volunteers:
  • Pain
  • Pain Medication
  • MRI incompatible
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic
  • Pain Patients:
  • MRI incompatible
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (6)

  • Shen B, Behera D, James ML, Reyes ST, Andrews L, Cipriano PW, Klukinov M, Lutz AB, Mavlyutov T, Rosenberg J, Ruoho AE, McCurdy CR, Gambhir SS, Yeomans DC, Biswal S, Chin FT. Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI. Theranostics. 2017 Jul 8;7(11):2794-2805. doi: 10.7150/thno.19378. eCollection 2017.

    PMID: 28824716BACKGROUND

  • Hjornevik T, Cipriano PW, Shen B, Park JH, Gulaka P, Holley D, Gandhi H, Yoon D, Mittra ES, Zaharchuk G, Gambhir SS, McCurdy CR, Chin FT, Biswal S. Biodistribution and Radiation Dosimetry of 18F-FTC-146 in Humans. J Nucl Med. 2017 Dec;58(12):2004-2009. doi: 10.2967/jnumed.117.192641. Epub 2017 Jun 1.

    PMID: 28572487BACKGROUND

  • Shen B, Park JH, Hjornevik T, Cipriano PW, Yoon D, Gulaka PK, Holly D, Behera D, Avery BA, Gambhir SS, McCurdy CR, Biswal S, Chin FT. Radiosynthesis and First-In-Human PET/MRI Evaluation with Clinical-Grade [18F]FTC-146. Mol Imaging Biol. 2017 Oct;19(5):779-786. doi: 10.1007/s11307-017-1064-z.

    PMID: 28280965BACKGROUND

  • Shen B, James ML, Andrews L, Lau C, Chen S, Palner M, Miao Z, Arksey NC, Shuhendler AJ, Scatliffe S, Kaneshige K, Parsons SM, McCurdy CR, Salehi A, Gambhir SS, Chin FT. Further validation to support clinical translation of [(18)F]FTC-146 for imaging sigma-1 receptors. EJNMMI Res. 2015 Dec;5(1):49. doi: 10.1186/s13550-015-0122-2. Epub 2015 Sep 17.

    PMID: 26384292BACKGROUND

  • 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: 24337599BACKGROUND

  • Yoon D, Fast AM, Cipriano P, Shen B, Castillo JB, McCurdy CR, Mari Aparici C, Lum D, Biswal S. Sigma-1 Receptor Changes Observed in Chronic Pelvic Pain Patients: A Pilot PET/MRI Study. Front Pain Res (Lausanne). 2021 Oct 20;2:711748. doi: 10.3389/fpain.2021.711748. eCollection 2021.

    PMID: 35295458DERIVED

MeSH Terms

Conditions

NeuralgiaNociceptive PainRadiculopathySpinal Cord DiseasesChronic Pain

Interventions

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

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System Diseases

Study Officials

  • Anand Veeravagu, MD

    Stanford University Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anand Veeravagu, MD

CONTACT

(650) 498-6154anand.veeravagu@stanford.edu

Adrian Valladarez

CONTACT

adrian98@stanford.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery

Study Record Dates

First Submitted

June 2, 2018

First Posted

June 14, 2018

Study Start

July 16, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)