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Not yet recruiting 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

Phase I Interventional Frozen Sections Indocyanine Green (ICG) Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cCeLL In vivo, Indocyanine Green.
Who it may be relevant to
Registry conditions: Frozen Sections, Indocyanine Green (ICG), Brain Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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
  • Drug Indocyanine Green
    fluorescence dye for staining tissue

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
  • Rate of Non-diagnostic Images with cCeLL [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
  • Diagnostic Time Comparison (cCeLL vs FS) [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
  • Time Required for cCeLL Imaging/Interpretation [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]
  • Detection of Positive Surgical Margins with cCeLL [Time frame: Visit 1 (Surgery Day / Intervention Day) as D-Day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07254845 · cCeLL_II_2025_Cedars

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗