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O estudo clínico NCT07254845 para Frozen Sections, Indocyanine Green (ICG), Tumor cerebral está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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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
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O estudo clínico NCT07254845 vai avaliar o diagnóstico para Frozen Sections, Indocyanine Green (ICG), Tumor cerebral. Este é um ensaio intervencionista de Fase I. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de dezembro de 2025, com o objetivo de incluir 30 participantes. Coordenado por VPIX Medical e deve ser concluído em 30 de agosto de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 28 de novembro de 2025.
Resumo
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.
Título oficial
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
Condições
Frozen SectionsIndocyanine Green (ICG)Tumor cerebralOutros IDs do estudo
- cCeLL_II_2025_Cedars
Número NCT
Data de início (real)
2025-12-01
Última atualização postada
2025-11-28
Data de conclusão (estimada)
2026-08-30
Inscrição (estimada)
30
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Palavras-chave
diagnostic imaging
intraoperative
confocal laser endomicroscopy
intraoperative
confocal laser endomicroscopy
Propósito principal
Diagnóstico
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalcCeLL - 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 Verde de indocianina fluorescence dye for staining tissue |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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 MedicalSem dados de contato.