Clinical trial NCT06867978: Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
Official title: A Prospective, Multi-Center, Assessor-Blinded Study on the Clinical Efficacy of CCeLL-In Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Frozen Sections
Indocyanine Green
Brain Tumor
Keywords: Diagnostic Imaging
intraoperative
confocal laser endomicroscopy
Lead sponsor: VPIX Medical
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective, multicenter, evaluator-blinded clinical trial evaluates the cCeLL - In vivo confocal laser fluorescence microscope for brain tumor diagnosis during surgery.

Intervention Summary Study Type: Interventional (Diagnostic) Design: Single-group assignment, evaluator-blinded

Intervention:

1. ICG injection during surgery
2. Fluorescence imaging of the tumor margin using cCeLL - In vivo
3. Comparison with standard frozen and permanent section analyses
4. Blinded evaluation by pathologists This study aims to enhance tumor margin assessment and improve diagnostic accuracy during brain tumor surgery.
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to demonstrate the non-inferiority of cCeLL 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, which is then read and analyzed by trained-professional for intraoperative diagnosis. The comparison will be held by the device with 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.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 years or older
* 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

The specimens used in this study must meet all of the following criteria:

* 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

Exclusion Criteria:

* Patients undergoing multiple surgeries
* Patients with bacterial or viral infections
* Patients who develop allergic reactions to the investigational medical device
* Patients with a history of allergy to Indocyanine Green (ICG)
* Patients with iodine hypersensitivity
* Patients taking choleretic agents or rifampicin

Specimens meeting any of the following criteria will be excluded from this clinical trial:

- Specimens with unclear tumor presence or carcinoma diagnosis results based on the reference standard permanent section analysis

Primary outcomes:
measure: Non-Inferiority of Diagnostic Accuracy (Percentage of Correct Normal/Tumor Classifications) of cCeLL Compared to Frozen Biopsy
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
Secondary outcomes:
measure: Diagnostic Accuracy, Sensitivity, and Specificity of cCeLL Compared to Frozen Biopsy Across Tumor Types and Locations
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
measure: Percentage of Non-Diagnostic Samples in cCeLL Imaging
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
measure: Time (Minutes) Required to Obtain a Diagnosis Using cCeLL-In vivo vs. Frozen Biopsy Description:
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
measure: Inter-Observer Agreement (Cohen's Kappa Score) Between Two Pathologists Using cCeLL-In vivo Images
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
measure: Diagnostic Accuracy (Percentage of Correct Tumor Classifications) of AI-Based Brain Tumor Diagnosis Using cCeLL-In vivo Images
timeFrame: Visit 1 (Surgery Day / Intervention Day) as D-Day
Other outcomes:
Locations:
Study officials:
References: