PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin

Phase 1

Not yet recruiting

• Conditions: Nerve Pain; Neuropathic Pain; Nociceptive Pain; MIxed Pain (Nociceptive and Neuropathic)
• Interventions: Drug: [18F]FTC-146

• Registration Number: NCT06599151
• Lead Sponsor: Stanford University

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

Detailed Description

Chronic pain represents a significant and widespread problem affecting approximately one-fifth person of the global population. As reported by the Institute of Medicine in 2011, chronic pain impacts 116 million American adults, surpassing the combined prevalence of heart disease, cancer, and diabetes. The economic burden associated with chronic pain is staggering, with an estimated annual expenditure of $635 billion on medical management and lost productivity1. Chronic pain can interfere with a person's daily life and lead to depression, insomnia and anxiety which can make the chronic pain worse. Chronic pain has many forms and appears across the body. For this study we will focus on chronic pain with spinal or peripheral nerve origin.

Chronic pain in the spinal cord or peripheral nerves can be caused by neuropathic pain, which occurs when the nervous system is damaged or malfunctions. Tumors, specifically schwannomas, are known to cause neuropathic chronic pain in subjects. The chronic pain can also be caused by nociceptive pain which is a type of pain that occurs when body tissue is damaged by physical or chemical agents, such as trauma, surgery, or chemical burns.

Pain is common and debilitating in people with schwannomatosis: Pain is the defining feature of most forms of schwannomatosis. While neurologic deficits (e.g., weakness) are relatively rare, pain is extremely common. Pain correlates with greater disability, and pain-related interference in daily activities correlates with poorer quality of life.

In patients with schwannomatosis, due to the presence of multiple tumors and frequent non-tumorigenic sources of pain, identifying the pain-generating tumor(s) can be difficult. This is particularly true since there does not seem to be any correlation between tumor size or active tumor growth and pain. Furthermore, even when pain can be localized to a specific nerve distribution, the nerve in question often will have multiple tumors along its course.

Current clinical methods for diagnosing and localizing pain generators are inadequate, highlighting the urgent need for more objective molecular assays capable of identifying sites of enhanced nociceptive activity. This will facilitate better diagnosis and targeted therapy for the patient. Additionally, the limited number availability of analgesic options for chronic and neuropathic pain patients, coupled with significant adverse effects, underscores the critical need for safer and better-tolerated analgesics.

Study Timeline

• Study First Submitted: 2024-08-21
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2030-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy Volunteers

  1. At least 18 years old.

• Pain Subjects

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

Exclusion Criteria

• Healthy Volunteers

  1. Any chronic Pain
  2. Use of pain medication.
  3. MRI incompatibility.
  4. Kidney problems.
  5. Pregnant or nursing.
  6. Non-English speaker.
  7. Presence of vasculopathy or Raynaud's.
  8. Inability to tolerate cessation of anticoagulant medication during the study.

• Pain Subjects

  1. MRI incompatibility.
  2. Kidney problems.
  3. Pregnant or nursing.
  4. Non-English speaker.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Patients With Spinal or Peripheral Nerve Origin	[18F]FTC-146	Individuals suffering from nerve pain that is of spinal or peripheral nerve origin and undergo a \[18F\]FTC-146 PET/MRI scan.
Healthy Volunteers	[18F]FTC-146	Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Primary Outcome Measures

Name	Time	Method
Biodistribution of [18F]FTC-146- correlate with reported pain	Estimated average of 4 hours	Correlation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level