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NCT Number: NCT07254845

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

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.

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Key information

Conditions

Frozen Sections Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Indocyanine Green (ICG) Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion 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
  • Tissue samples must be adequate for both FS and PS analysis
  • Minimum lesion size of 1 cm for reliable cCeLL imaging

Treatment and study plan

cCeLL In vivo

Device

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

Indocyanine green

Drug

fluorescence dye for staining tissue

Primary outcomes

  1. The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard.

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    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.

Secondary outcomes

  1. Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    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.

  2. Rate of Non-diagnostic Images with cCeLL

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    The number of non-diagnostic cCeLL images will be reported, with N_ND representing non-diagnostic images and N_Total the total images acquired.

  3. Diagnostic Time Comparison (cCeLL vs FS)

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    Acquisition and interpretation times for cCeLL and FS will be summarized, with differences described; a positive value indicates time saved using cCeLL.

  4. Time Required for cCeLL Imaging/Interpretation

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    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.

  5. Detection of Positive Surgical Margins with cCeLL

    Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day

    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

Sponsors and collaborators

Lead sponsor

VPIX Medical

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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