PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin

NCT06599151 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 76036
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 with Spinal or Peripheral Nerve Origin. Primary Objectives: A) To quantify the bio-distribution of \[18F\] FTC-146 uptake in subjects with Spinal or Peripheral Nerve Origin pain and compare it with healthy controls. B) To determine whether painful schwannomas can be differentiated from non-painful schwannomas based on imaging. Secondary Objectives: A) To assess the reproducibility of \[18F\]FTC-146 PET imaging within the same healthy volunteer subjects using Test-Retest analysis. B) To investigate whether post-treatment \[18F\]FTC-146 uptake differs from pre-treatment uptake and correlate the imaging with subject reported pain level after treatment

Conditions

Nerve Pain; Neuropathic Pain; Nociceptive Pain; MIxed Pain (Nociceptive and Neuropathic)

Keywords

PET/MRI; Chronic Pain; Nerve Pain

Outcome Measures

Primary Outcomes (1)

• Biodistribution of [18F]FTC-146- correlate with reported pain

  Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level

  Estimated average of 4 hours

Study Arms (2)

Pain Patients With Spinal or Peripheral Nerve Origin

EXPERIMENTAL

Individuals suffering from nerve pain that is of spinal or peripheral nerve origin 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-146 DRUG

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

Healthy Volunteers; Pain Patients With Spinal or Peripheral Nerve Origin

Eligibility Criteria

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

You may qualify if:

• Healthy Volunteers
• \. At least 18 years old.
• Pain Subjects
• At least 18 years old.
• Chronic Pain is of Spinal or Peripheral Nerve Origin
• Subject's Chronic pain lasting greater than 2 months.
• Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.

You may not qualify if:

• Healthy Volunteers
• Any chronic Pain
• Use of pain medication.
• MRI incompatibility.
• Kidney problems.
• Pregnant or nursing.
• Non-English speaker.
• Presence of vasculopathy or Raynaud's.
• Inability to tolerate cessation of anticoagulant medication during the study.
• Pain Subjects
• MRI incompatibility.
• Kidney problems.
• Pregnant or nursing.
• Non-English speaker.

Sponsors & Collaborators

• Stanford University: lead

Related Publications (4)

• 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: 28824716 BACKGROUND

• 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: 28280965 BACKGROUND

• 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

• Entrena JM, Cobos EJ, Nieto FR, Cendan CM, Baeyens JM, Del Pozo E. Antagonism by haloperidol and its metabolites of mechanical hypersensitivity induced by intraplantar capsaicin in mice: role of sigma-1 receptors. Psychopharmacology (Berl). 2009 Jul;205(1):21-33. doi: 10.1007/s00213-009-1513-8. Epub 2009 Mar 27.

  PMID: 19326101 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Nociceptive Pain; Chronic Pain

Interventions

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

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anand Veeravagu

  Stanford University- Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Valladarez

CONTACT

(650) 381-4257; adrian98@stanford.edu

Neurosurgery Research Team

CONTACT

neurosurgeryresearch@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Asst. Professor

Model Details: All enrolled subjects (Pain Patients and Healthy Volunteers) will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share