Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.

Get Involved

Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06867978
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	VPIX Medical
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Frozen Sections, Indocyanine Green, Brain Tumor

Arms & Interventions

Arms

Experimental: cCeLL - 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.

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