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临床试验/NCT07121985
NCT07121985尚未招募不适用

Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy

University of Erlangen-Nürnberg Medical School0 个研究点目标入组 30 人开始时间: 2025年8月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Single Wavelength PA signal

研究概览

简要总结

The aim of this study is to assess disease activity in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Guillain-Barré Syndrome (GBS) using multispectral optoacoustic tomography (MSOT).

The currently available diagnostic procedures for CIDP and GBS do not allow for a clear distinction between remission and active disease and show limitations in sensitivity and specificity during acute diagnostics. This can lead to delayed diagnosis, which is crucial for timely initiation of therapy and, consequently, for a better prognosis. Long-term therapy management is also challenging, as objective parameters for assessing therapeutic success are largely lacking.

MSOT can detect inflammation through the measurement of hemoglobin, a method that our research group has already successfully demonstrated in patients with chronic inflammatory bowel diseases (Knieling, NEJM 2017). The use of MSOT could therefore also be applied to nerve inflammation, allowing for earlier detection of inflammation and nerve damage and contributing to timely treatment of patients.

For nerve imaging, a CE-certified MSOT device from iThera Medical is available at the Pediatric Clinic in Erlangen. In addition, a non-CE-certified device with lower laser power is available, which can be used for bedside examinations.

The arm nerves will be examined in three cohorts, which will be compared with each other and with standard diagnostics (blood tests, electrophysiology, conventional ultrasound).

Each cohort will include ten healthy control subjects, ten patients with CIDP, and ten patients with GBS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • Pregnancy
  • Breastfeeding mothers
  • Cardiopulmonary instability
  • Tattoo in the examination area
  • Subcutaneous fat tissue > 3 cm

结局指标

主要结局

Single Wavelength PA signal

时间窗: Single time point

Photoacoustic single wavelength signal between 700nm and 1100nm in the measured nerves.

PA hemoglobin signal

时间窗: Single time point

Unmixed photoacoustic hemoglobin signal (oxygenated, deoxygenated and derived saturation) in the measured nerves

Doppler signal

时间窗: Single time point

Ultrasound-based Doppler signal in the measured nerves

次要结局

  • Nerve diameter(Single time point)
  • Clinical scores(Single time point)
  • PA lipid signal(Single time point)
  • PA water signal(Single time point)
  • PA collagen signal(Single time point)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferdinand Knieling

PD Dr. med. Dr. Humanbiol.

University of Erlangen-Nürnberg Medical School

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