A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the cCeLL-Ex Vivo Device for Intraoperative Brain Tumor Diagnosis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 285
- 试验地点
- 5
- 主要终点
- Clinical Sensitivity for Tumor Detection (Specimen-level)
研究概览
简要总结
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing staffing demands. Confocal Laser Fluorescence Microscopy (cCeLL - Ex vivo) acquires real-time, high-resolution fluorescence images of resected tissue and therefore may serve as a rapid alternative or adjunct to frozen sections. This prospective, multi-center study was designed to systematically assess the clinical performance of cCeLL - Ex vivo during brain-tumor surgery.
详细描述
Primary Objective
Demonstrate non-inferiority of cCeLL - Ex vivo versus frozen-section histopathology in terms of clinical sensitivity and specificity for intra-operative brain-tumor diagnosis.
Secondary Objectives Compare diagnostic turnaround time between cCeLL - Ex vivo and frozen section. Evaluate tumor-type classification accuracy for each modality. Determine the average number of images required for definitive cCeLL - Ex vivo interpretation.
Quantify overall diagnostic performance of cCeLL - Ex vivo using the area under the ROC curve (AUC).
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
This trial employed an assessor-blinded design. Specifically, the pathologist who interpreted the cCeLL - Ex vivo images had no access to the patient's clinical information, frozen section results, or permanent section results. By ensuring that the individual responsible for cCeLL - Ex vivo image interpretation was blinded to other diagnostic data, the study minimized bias in determining sensitivity and specificity outcomes.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specimens and images used in this study must meet all of the following criteria:
- •Tissue obtained from male or female patients aged 19 years or older.
- •Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor.
- •Tissue obtained from patients capable of understanding and signing the informed consent form.
排除标准
- •Specimens and images that meet any of the following criteria will be excluded from the study:
- •Emergency cases where informed consent could not be obtained before surgery.
- •Specimens with significant hemorrhage, affecting image quality.
- •Small biopsy specimens that do not meet the required size for imaging.
- •Poor-quality images that do not meet study criteria, including:
- •Low-quality cCeLL - Ex vivo images.
- •Non-diagnostic cCeLL - Ex vivo images of the tumor core.
- •Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results.
- •Patients undergoing multiple surgeries at the same site.
结局指标
主要结局
Clinical Sensitivity for Tumor Detection (Specimen-level)
时间窗: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
Clinical Specificity for Tumor Detection (Specimen-level)
时间窗: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows
次要结局
未报告次要终点