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临床试验 NCT07254845 针对Frozen Sections，Indocyanine Green (ICG)，脑肿瘤目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS
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临床试验NCT07254845旨在研究诊断，主要针对Frozen Sections，Indocyanine Green (ICG)，脑肿瘤。这是一项I期 (第一期) 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年12月1日开始，预计招募30名患者。该研究由VPIX Medical主导，计划于2026年8月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月28日。
简要概括
The primary objective of this single-center study is to demonstrate the performance of cCeLL, used in real time, 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, and the images will be immediately transmitted to a single pathologist for real-time evaluation, without influencing the surgical decision-making process. The comparison will be made between the device and 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.
官方标题
A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS
疾病
Frozen SectionsIndocyanine Green (ICG)脑肿瘤其他研究标识符
- cCeLL_II_2025_Cedars
NCT编号
实际开始日期
2025-12-01
最近更新发布
2025-11-28
预计完成日期
2026-08-30
计划入组人数
30
研究类型
干预性研究
试验分期 (阶段)
I期 (第一期)
试验状态
尚未招募
关键词
diagnostic imaging
intraoperative
confocal laser endomicroscopy
intraoperative
confocal laser endomicroscopy
主要目的
诊断
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | Ccell in Vivo Dosage Form: Intravenous injection Dosage: 0.1 - 0.5 mg/kg of Indocyanine Green (ICG) Frequency: Single administration during surgery Duration: Real-time imaging performed immediately after ICG injection and used intraoperatively for tumor margin assessment 吲哚菁绿 fluorescence dye for staining tissue |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard. | cCeLL and FS diagnostic accuracy will be compared to PS, reporting sensitivity, specificity, PPV, NPV, and overall accuracy with 95% CIs. Analyses are descriptive, summarized by dataset, tumor type, and sampling site. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites | Diagnostic indices (sensitivity, specificity, accuracy) will be calculated for each tumor type and sampling site using PS as the reference.
cCeLL and FS performance will be compared side by side within subgroups descriptively, without statistical testing due to small sample sizes. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
Rate of Non-diagnostic Images with cCeLL | The number of non-diagnostic cCeLL images will be reported, with N\_ND representing non-diagnostic images and N\_Total the total images acquired. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
Diagnostic Time Comparison (cCeLL vs FS) | Acquisition and interpretation times for cCeLL and FS will be summarized, with differences described; a positive value indicates time saved using cCeLL. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
Time Required for cCeLL Imaging/Interpretation | The average and range of regions imaged per case, along with cCeLL acquisition and interpretation times, will be summarized to assess operational feasibility and real-time workflow integration during neurosurgery. | Visit 1 (Surgery Day / Intervention Day) as D-Day |
Detection of Positive Surgical Margins with cCeLL | For post-resection scans, biopsies will be performed only if cCeLL is positive, and the Positive Margin Detection Rate will be used to assess cCeLL's ability to identify residual tumor at surgical margins | Visit 1 (Surgery Day / Intervention Day) as D-Day |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Male or female patients aged 18 years or older as of the screening date
- 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
- 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
- Tissue samples must be adequate for both FS and PS analysis
- Minimum lesion size of 1 cm for reliable cCeLL imaging
VPIX Medical没有联系数据。