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PETMRI for Chronic Pain from Spinal or Peripheral Nerve Origin

Use of (18F)FTC-146 PET_MRI for Characterizing Chronic Pain Phenotypes in Chronic Pain Patients with Spinal or Peripheral Nerve Origin

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06599151
Enrollment
200
Registered
2024-09-19
Start date
2024-10-01
Completion date
2030-10-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PET/MRI, Chronic Pain, Nerve Pain

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.

Interventions

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

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Biodistribution of [18F]FTC-146- correlate with reported painEstimated average of 4 hoursCorrelation of Standardized Uptake Value max (SUVmax) value with the participant's reported pain level

Contacts

Primary ContactAdrian Valladarez
adrian98@stanford.edu(650) 381-4257
Backup ContactNeurosurgery Research Team
neurosurgeryresearch@stanford.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026