跳至主要内容
临床试验/NCT06599151
NCT06599151尚未招募1 期

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

Stanford University0 个研究点目标入组 200 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
200
主要终点
Biodistribution of [18F]FTC-146- correlate with reported pain

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: [18F]FTC-146 (Drug)

Healthy Volunteers

Experimental

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

干预措施: [18F]FTC-146 (Drug)

结局指标

主要结局

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

时间窗: Estimated average of 4 hours

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anand Veeravagu

M.D. Asst. Professor

Stanford University

相似试验