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临床试验/NCT04435821
NCT04435821已完成1 期

Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain

Stanford University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年11月19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
已完成
入组人数
5
试验地点
1
主要终点
[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients

研究概览

简要总结

[18F]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation and perpetuation of chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for treatment of chronic pain. Using [18F]-FTC-146 and PET/MRI, we hope to learn what is the best approach to identify the source of pain generation and characterize the disease in pediatric patients with chronic pain.

详细描述

It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic pain. As a result of chronic pain, children may miss school, withdraw from social activities, and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's pain is important for both proper treatment of the pain and to prevent problems secondary to the chronic pain. Evidence in the literature points strongly toward an involvement of the sigma-1 receptor in neurogenic inflammation, which is known to be an important pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain. The investigators hope to image and identify activated pain pathways in pediatric pain paitents using a radiolabeled biomarker for increased S1R expression. By localizing and quantifying areas of increased S1R expression to sites of augmented nociceptive activity using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of neurogenic inflammatory activity and pain generation. The ability to image the changes associated with chronic pain generating pathologies provides us with a tool to identify and measure the intensity of the pathology. Imaging S1R expression in chronic pain states in pediatric patients would be both novel in its application and extremely powerful in better characterizing pediatric pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • 11-18 years old.
  • Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months.
  • Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of screening).
  • 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

  • MRI incompatible
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

研究组 & 干预措施

Pediatric Chronic Pain Patients

Experimental

Individuals 11-18 years old, with chronic pain (lasting at least 2 months).

干预措施: [18F]FTC-146 (Drug)

结局指标

主要结局

[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients

时间窗: 3 hours

Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

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

Helen Ruth Nadel

Clinical Professor

Stanford University

研究点 (1)

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