Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy
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
- 是
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
Ferdinand Knieling
PD Dr. med. Dr. Humanbiol.
University of Erlangen-Nürnberg Medical School
