Trial Radar IA | ||
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Lo studio clinico NCT07254845 per Frozen Sections, Indocyanine Green (ICG), Tumore cerebrale è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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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
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07254845 è uno studio interventistico di Fase I volto a esaminare la diagnostica per Frozen Sections, Indocyanine Green (ICG), Tumore cerebrale, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 dicembre 2025, con l'obiettivo di raggiungere 30 partecipanti. Sotto la guida di VPIX Medical, dovrebbe concludersi entro il 30 agosto 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 novembre 2025.
Sommario breve
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.
Titolo ufficiale
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
Condizioni
Frozen SectionsIndocyanine Green (ICG)Tumore cerebraleAltri ID dello studio
- cCeLL_II_2025_Cedars
Numero NCT
Data di inizio (effettiva)
2025-12-01
Ultimo aggiornamento pubblicato
2025-11-28
Data di completamento (stimata)
2026-08-30
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Parole chiave
diagnostic imaging
intraoperative
confocal laser endomicroscopy
intraoperative
confocal laser endomicroscopy
Scopo principale
Diagnostico
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentalecCeLL - 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 indocianina fluorescence dye for staining tissue |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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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