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क्लिनिकल ट्रायल NCT07254845 के लिए Frozen Sections, Indocyanine Green (ICG), मस्तिष्क ट्यूमर वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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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

अभी भर्ती शुरू नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT07254845 का मुख्य उद्देश्य नैदानिक का अध्ययन करना है। यह चिकित्सकीय अध्ययन Frozen Sections, Indocyanine Green (ICG), मस्तिष्क ट्यूमर से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 30 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 दिसंबर 2025 से शुरू होगा। VPIX Medical इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 अगस्त 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 28 नवंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
आधिकारिक शीर्षक

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

चिकित्सीय स्थितियाँ
Frozen SectionsIndocyanine Green (ICG)मस्तिष्क ट्यूमर
अन्य अध्ययन आईडी
  • cCeLL_II_2025_Cedars
NCT नंबर
NCT07254845
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-12-01
अंतिम अद्यतन प्रकाशित
2025-11-28
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-08-30
नामांकन (अनुमानित)
30
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
diagnostic imaging
intraoperative
confocal laser endomicroscopy
प्राथमिक उद्देश्य
नैदानिक
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकcCeLL - 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
इंडोसाइनिन ग्रीन
fluorescence dye for staining tissue
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  1. Male or female patients aged 18 years or older as of the screening date
  2. Patients suspected of having a brain tumor who are scheduled for neurosurgery and are considered candidates for tumor resection
  3. Patients who understand and have signed the informed consent form

  1. Specimens obtained from patients who have agreed to participate in this clinical trial and who meet the inclusion criteria
  2. Normal tissue specimens obtained unavoidably during tumor resection surgery in tumor patients
  3. Tissue samples must be adequate for both FS and PS analysis
  4. Minimum lesion size of 1 cm for reliable cCeLL imaging
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