Molecular Imaging-Based Cryoneurolysis: Targeting Upregulated Sigma-1 Receptor Positive Nerves in Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 主要终点
- Pain Scores and Functional Interference (Pain Disability Index [PDI])
研究概览
简要总结
The goal of this clinical trial is to determine whether a sigma-1 receptor PET/MRI scan can help identify the specific nerves responsible for chronic pain.
Researchers will use an investigational imaging agent called [18F]FTC-146 to look for signs of pain generating nerve irritation or injury that may not be visible on convention imaging tests.
Participants whose pain-generating nerve can be identified may undergo a diagnostic nerve block and, if successful, a standard clinical procedure called cryoneurolysis will be used to temporarily interrupt pain signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Chronic nociceptive, neuropathic, or mixed pain for ≥2 months
- •Pain originating from a region amenable to cryoneurolysis (celiac plexus, intercostal nerves, pudendal nerve, peripheral nerve block
- •Chronic pain ≥2 months
- •Pain score ≥4/10
- •Pain location amenable to cryoneurolysis
- •Willing and able to provide consent.
排除标准
- •Pregnancy or nursing.
- •Non-English speaking individuals
- •Contraindication to MRI scanning which includes, but is not limited to, incompatible metal or hardware including pacemakers, cochlear implants, and bullets near a critical organ.
- •Weight >350 pounds or a large body habitus, which the MR scanner cannot accommodate.
- •Claustrophobia or feeling that he or she will be unable to lie still in the scanner for a period of 2 hours or fit in the PET/MR scanner due to body size.
研究组 & 干预措施
Experimental: [18F]-FTC-146
All participants will receive an injection of 5-10 mCi [18F]FTC-146 formulated in a sterile and pyrogen-free isotonic solution followed by PET/MRI to identify sites of increased sigma-1 receptor (S1R) activity suggestive of pain generating nerve irritation or injury.
Eligible patients with clinical symptoms correlating to the site of abnormal uptake on [18F]FTC-146 PET/MRI will then undergo cross-sectional (+/- ultrasound) -guided nerve block of the S1R positive site.
If a patient notices a significant improvement in pain (≥50%), percutaneous cryoneurolysis of the S1R-positive site will then be performed within 1-4 weeks of the initial nerve block.
干预措施: [18F]-FTC-146 (Drug)
结局指标
主要结局
Pain Scores and Functional Interference (Pain Disability Index [PDI])
时间窗: Assessed at baseline (pre-procedure) and at 1, 3, 6, and 12 months following cryoneurolysis.
The Pain Score measures pain intensity on a numeric or visual scale, from 0 to 10. The Pain Disability Index (PDI) measures how much pain limits a person's daily life across seven functional areas, scoring impact from 0 to 10 for each category.
次要结局
- Pain medication(1, 3, 6, 12 months)
- Imaging Correlation(At time of imaging and clinical assessment prior to intervention)
- Procedural Correlation(at 1 month post procedure)
研究者
Lynne N Martin
Clinical Assistant Professor in Radiology
Stanford University