임상 레이더 AI | ||
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임상시험 NCT07254845은(는) Frozen Sections, Indocyanine Green (ICG), 뇌 종양에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
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
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07254845은(는) 진단을(를) 알아보기 위한 연구입니다. 이 연구는 Frozen Sections, Indocyanine Green (ICG), 뇌 종양에 대해 진행되며, 1상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2025년 12월 1일부터 가능하며, 30명의 참여자를 모집할 예정입니다. VPIX Medical이(가) 진행하는 이 연구는 2026년 8월 30일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 28일에 갱신되었습니다.
간단한 개요
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.
공식 제목
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
질환/상태
Frozen SectionsIndocyanine Green (ICG)뇌 종양기타 연구 식별자
- cCeLL_II_2025_Cedars
NCT 번호
실제 연구 시작일
2025-12-01
최신 업데이트 게시
2025-11-28
예상 연구 완료일
2026-08-30
계획된 등록 인원
30
연구종류
중재연구
단계/상
1상
상태
대상자모집전
키워드
diagnostic imaging
intraoperative
confocal laser endomicroscopy
intraoperative
confocal laser endomicroscopy
주요 목적
진단
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적cCeLL - 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 인도시아닌 그린 fluorescence dye for staining tissue |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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
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