A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy
研究概览
简要总结
The primary objective of this study is to demonstrate the non-inferiority of cCeLL compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovascular before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, which is then read and analyzed by trained-professional for intraoperative diagnosis. The comparison will be held by the device with the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. Both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis.
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
盲法说明
Pathologists will perform diagnoses without access to patient medical records and will not see prior diagnostic results. They will assess tissue samples using only de-identified information, ensuring that fluorescence imaging results do not influence their evaluation. This approach eliminates bias and maintains the integrity of the study's diagnostic comparison.
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
- •Male or female patients aged 18 years or older
- •Patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection
- •Patients who understand and have signed the informed consent form
- •The specimens used in this study must meet all of the following criteria:
- •Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
- •Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients
排除标准
- •Patients undergoing multiple surgeries
- •Patients with bacterial or viral infections
- •Patients who develop allergic reactions to the investigational medical device
- •Patients with a history of allergy to Indocyanine Green (ICG)
- •Patients with iodine hypersensitivity
- •Patients taking choleretic agents or rifampicin
- •Specimens meeting any of the following criteria will be excluded from this clinical trial:
- •Specimens with unclear tumor presence or carcinoma diagnosis results based on the reference standard permanent section analysis
研究组 & 干预措施
cCeLL - In vivo Imaging
Participants diagnosed with brain tumors will receive an intravenous injection of Indocyanine Green (ICG) during surgery. The cCeLL - In vivo confocal laser fluorescence microscope will be used to capture real-time images of the tumor margins before tissue collection. Standard frozen section and permanent section analyses will then be performed for diagnostic comparison.
干预措施: cCeLL In vivo (Device)
cCeLL - In vivo Imaging
Participants diagnosed with brain tumors will receive an intravenous injection of Indocyanine Green (ICG) during surgery. The cCeLL - In vivo confocal laser fluorescence microscope will be used to capture real-time images of the tumor margins before tissue collection. Standard frozen section and permanent section analyses will then be performed for diagnostic comparison.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy
时间窗: Visit 1 (Surgery Day / Intervention Day) as D-Day
The diagnostic accuracy of cCeLL-In vivo will be assessed by measuring the percentage of correct normal/tumor classifications compared to the reference standard frozen biopsy. Non-inferiority will be determined using pre-specified statistical margins for sensitivity and specificity.
次要结局
- Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations(Visit 1 (Surgery Day / Intervention Day) as D-Day)
- Percentage of Non-Diagnostic Samples in cCeLL Imaging(Visit 1 (Surgery Day / Intervention Day) as D-Day)
- Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images(Visit 1 (Surgery Day / Intervention Day) as D-Day)
- Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:(Visit 1 (Surgery Day / Intervention Day) as D-Day)
- Diagnostic Accuracy (Percentage of Correct Tumor Classifications) of AI-Based Brain Tumor Diagnosis Using cCeLL-In vivo Images(Visit 1 (Surgery Day / Intervention Day) as D-Day)