Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- [18F]FTC-146 Biodistribution in Pain Patients
研究概览
简要总结
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.
详细描述
Chronic pain is a significant, widespread problem affecting every fifth person worldwide. Reported in 2011 by the Institute of Medicine, chronic pain affects 116 million American adults - more than the total number of individuals affected by heart disease, cancer, and diabetes combined. An estimated $635 billion each year is spent in the medical management of chronic pain and lost productivity. Better clinical methods to diagnose and localize pain are needed.
The investigators have developed a S1R-specific radiotracer, [18F]FTC-146. Using imaging approaches to assess the location of S1R in pain may provide a tool to diagnose pain generators, monitor treatment response, and aid in the selection of patients for treatment.
The goal is to use [18F]FTC-146 to image S1R expression in healthy volunteers and to compare the images to those individuals suffering from pain conditions in the following categories: (1) nociceptive pain (pain that results from tissue injury or inflammation), (2) neuropathic pain (pain that results from direct injury, disruption, impingement/compression or malfunction of the peripheral and/or central nervous system), and (3) mixed pain (pain that appears to have both nociceptive and neuropathic).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •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.
排除标准
- •Healthy Volunteers:
- •Pain Medication
- •MRI incompatible
- •Pregnant or nursing
- •Non-English speaker
- •Claustrophobic
- •Pain Patients:
- •MRI incompatible
- •Pregnant or nursing
- •Non-English speaker
- •Claustrophobic
研究组 & 干预措施
Pain Patients
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.
干预措施: [18F]FTC-146 (Drug)
Healthy Volunteers
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
[18F]FTC-146 Biodistribution in Pain Patients
时间窗: Estimated average of 3 hours
Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
[18F]FTC-146 Biodistribution in Healthy Volunteers
时间窗: Estimated average of 3 hours
Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.
次要结局
未报告次要终点
研究者
Anand Veeravagu
Assistant Professor of Neurosurgery
Stanford University