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临床试验/NCT03019029
NCT03019029已完成1 期

Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年3月13日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
8
试验地点
1
主要终点
Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)

研究概览

简要总结

The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare these results to non-amyloid diseased controls.

详细描述

Patients with pathologically proven amyloidosis involving the peripheral nervous system will undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A control arm comprised of patients with pathologically-confirmed non-amyloid causes of peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be reviewed for peripheral nerve uptake.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults: 18-100
  • Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed non-amyloid causes of peripheral neuropathy

排除标准

  • Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.)
  • Claustrophobia
  • BMI over 38

研究组 & 干预措施

Peripheral nerve amyloidosis

Experimental

Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.

干预措施: 18-F Florbetapir PET/MR scan (Other)

结局指标

主要结局

Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)

时间窗: 50-120 minutes post injection

Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.

Locations of peripheral nerve 18-F Florbetapir uptake

时间窗: 50-120 minutes post injection

Standardized uptake value (SUV)

次要结局

  • Additional sites of 18-F Florbetapir uptake(50-120 minutes post injection)
  • Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement)(50-120 minutes post injection)
  • Morphologic changes(50-120 minutes post injection)
  • T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle)(50-120 minutes post injection)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor
主要研究者

Stephen M. Broski

Principal Investigator

Mayo Clinic

研究点 (1)

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