Benign Brain TumorcCeLLExvivoNCT06098248

Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis

A study testing cCeLL - Ex vivo in people with Benign Brain Tumor and Malignant Brain Tumor, run by VPIX Medical at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Benign Brain Tumor, Malignant Brain Tumor
What is being tested?: cCeLL - Ex vivo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 285 participants
Where: 4 sitesin 2 countries
Study dates: 1 Jan 2023to 27 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Specimens and images used in this study must meet all of the following criteria:
Tissue obtained from male or female patients aged 19 years or older.
Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor.
Tissue obtained from patients capable of understanding and signing the informed consent form.

Who cannot join

Specimens and images that meet any of the following criteria will be excluded from the study:
Emergency cases where informed consent could not be obtained before surgery.
Specimens with significant hemorrhage, affecting image quality.
Small biopsy specimens that do not meet the required size for imaging.
Poor-quality images that do not meet study criteria, including:
Low-quality cCeLL - Ex vivo images.

Show all 9Show fewer

Non-diagnostic cCeLL - Ex vivo images of the tumor core.
Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results.
Patients undergoing multiple surgeries at the same site.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

South Korea3 sites

Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul

Other trials in South Korea

Canada1 site

St. Michael's Hospital
Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the cCeLL-Ex Vivo Device for Intraoperative Brain Tumor Diagnosis.

Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing staffing demands. Confocal Laser Fluorescence Microscopy (cCeLL - Ex vivo) acquires real-time, high-resolution fluorescence images of resected tissue and therefore may serve as a rapid alternative or adjunct to frozen sections. This prospective, multi-center study was designed to systematically assess the clinical performance of cCeLL - Ex vivo during brain-tumor surgery.

Read the detailed description

Primary Objective

Demonstrate non-inferiority of cCeLL - Ex vivo versus frozen-section histopathology in terms of clinical sensitivity and specificity for intra-operative brain-tumor diagnosis.

Secondary Objectives Compare diagnostic turnaround time between cCeLL - Ex vivo and frozen section. Evaluate tumor-type classification accuracy for each modality. Determine the average number of images required for definitive cCeLL - Ex vivo interpretation.

Quantify overall diagnostic performance of cCeLL - Ex vivo using the area under the ROC curve (AUC).

Conditions: Benign Brain Tumor, Malignant Brain Tumor
Being tested: cCeLL - Ex vivo
Keywords: Brain Tumor, Brain Tumor Surgery, Cancer Surgery, Brain Tumor Resection, Biopsy, Digital Biopsy, Frozen Section
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cCeLL - Ex vivoDiagnostic test
Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

Study groups in NCT06098248
Study group	Role	What they receive
Patients already scheduled for brain tumor surgery	Experimental	Study Arms and Intervention This study compares cCeLL - Ex vivo imaging (test) and frozen section histopathology (control) against permanent section histopathology (reference standard). * Test Arm: Uses confocal laser fluorescence microscopy (CLFM) for real-time imaging of resected tumor tissues, analyzed by blinded pathologists. * Control Arm: Standard H\&E-stained frozen section, requiring tissue processing (30-40 min) for intraoperative diagnosis. The study evaluates diagnostic accuracy, sensitivity, and specificity of cCeLL - Ex vivo imaging. Receives: Diagnostic Test: cCeLL - Ex vivo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Sensitivity for Tumor Detection (Specimen-level)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
Measured: From neurosurgical resection to permanent pathology (≈ 4 weeks)
Clinical Specificity for Tumor Detection (Specimen-level)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows
Measured: From neurosurgical resection to permanent pathology (≈ 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202327 Nov 2024

First posted24 Oct 2023
Study start1 Jan 2023
Primary completion27 Nov 2024
Study completion27 Nov 2024

Why it stopped: Delays in specimen recruitment have increased costs and strained resources, risking study validity. To maintain ethical and scientific integrity, the study will be terminated early.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Benign Brain TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: * All enrolled participants were assigned to the same intervention (i.e., cCeLL - Ex vivo), with no separate control group or comparator. * The study's primary purpose was to evaluate the diagnostic performance (sensitivity, specificity) of the investigational device in a single cohort of participants undergoing brain tumor resection.
Masking: None (open label)
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06098248
Sponsor's protocol ID: cCell_Ex vivo-01
Other IDs: Republic of Korea
Acronym: cCeLLExvivo
Status last verified: Nov 2025
First submitted: 5 Oct 2023
Last updated: 15 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Amos WB, White JG. How the confocal laser scanning microscope entered biological research. Biol Cell. 2003 Sep;95(6):335-42. doi: 10.1016/s0248-4900(03)00078-9.
PubMed 14519550
BIS Research Inc. Medical market data. Updated 2022. https://blog.bisresearch.com/bis-research-market-insights-quick-bytes
Carl Zeiss Meditec AG. Convivo: Putting in vivo cellular imaging at your fingertips. 2019:Brochure. Available at: https://www.zeiss.com/content/dam/Meditec/ref_master/products/convivo/documents/convivo_brochure.pdf
Chand P, Amit S, Gupta R, Agarwal A. Errors, limitations, and pitfalls in the diagnosis of central and peripheral nervous system lesions in intraoperative cytology and frozen sections. J Cytol. 2016 Apr-Jun;33(2):93-7. doi: 10.4103/0970-9371.182530.
PubMed 27279685
de Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17.
PubMed 31862245
Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2020 (https://gco.iarc.fr/today, accessed February 2021).
IndustryARC. Oncology Market - Forecast (2020 - 2025). 2020.
Mat Zin AA, Zulkarnain S. Diagnostic Accuracy of Cytology Smear and Frozen Section in Glioma. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):321-325. doi: 10.31557/APJCP.2019.20.2.321.
PubMed 30803189
Mauna Kea Technologies. Cellvizio: Real-time in vivo cellular imaging platform. 2021:Brochure. Available at: http://www.cellvizio.net/uploads/media/media_pdf/0001/03/MKT-132-EN-Cellvizio%20Web%20Brochure.pdf
MAVIG GmbH. Vivascope: Confocal laser scanning microscopy - In vivo histology for cellular level skin analyses in cosmetic research and dermopharmacy. 2019:Brochure. Available at: https://www.vivascope.de/wp-content/uploads/2019/06/Cosmeticbrochure.pdf
Samal S, Kalra R, Sharma J, et al. Comparison between crush/squash cytology and frozen section preparation in intraoperative diagnosis of central nervous system lesions. Oncol J India. 2018;1:25-30.
Tofte K, Berger C, Torp SH, Solheim O. The diagnostic properties of frozen sections in suspected intracranial tumors: A study of 578 consecutive cases. Surg Neurol Int. 2014 Dec 3;5:170. doi: 10.4103/2152-7806.146153. eCollection 2014.
PubMed 25593754
White JG, Amos WB, Fordham M. An evaluation of confocal versus conventional imaging of biological structures by fluorescence light microscopy. J Cell Biol. 1987 Jul;105(1):41-8. doi: 10.1083/jcb.105.1.41.
PubMed 3112165
WHO. Assessing national capacity for the prevention and control of noncommunicable diseases: report of the 2019 global survey. Geneva: World Health Organization; 2020.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
Stroke, Brain Injuries, Traumatic
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
Not yet recruiting
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Glioma, Glioma Intracranial

All Benign Brain Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the cCeLL-Ex Vivo Device for Intraoperative Brain Tumor Diagnosis.
ClinicalTrials.gov ID: NCT06098248
Acronym / sponsor ID: cCeLLExvivo / cCell_Ex vivo-01
Conditions: Benign Brain Tumor, Malignant Brain Tumor
Keywords: Brain Tumor, Brain Tumor Surgery, Cancer Surgery, Brain Tumor Resection, Biopsy, Digital Biopsy, Frozen Section
Study type: Interventional
Recruitment status: TerminatedReason stopped: Delays in specimen recruitment have increased costs and strained resources, risking study validity. To maintain ethical and scientific integrity, the study will be terminated early.
Enrolment: 285 participants (actual)
Lead sponsor: VPIX MedicalIndustry (pharma, biotech, devices)
Collaborators: Unity Health Toronto, Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital
Study start: 1 Jan 2023 (actual)
Primary completion: 27 Nov 2024 (actual)
Study completion: 27 Nov 2024 (actual)
First posted: 24 Oct 2023 (actual)
Results: Posted 15 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective

Demonstrate non-inferiority of cCeLL - Ex vivo versus frozen-section histopathology in terms of clinical sensitivity and specificity for intra-operative brain-tumor diagnosis.

Quantify overall diagnostic performance of cCeLL - Ex vivo using the area under the ROC curve (AUC).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: * All enrolled participants were assigned to the same intervention (i.e., cCeLL - Ex vivo), with no separate control group or comparator. * The study's primary purpose was to evaluate the diagnostic performance (sensitivity, specificity) of the investigational device in a single cohort of participants undergoing brain tumor resection.

Arm	Type	Receives
Patients already scheduled for brain tumor surgery	Experimental	Diagnostic Test: cCeLL - Ex vivoStudy Arms and Intervention This study compares cCeLL - Ex vivo imaging (test) and frozen section histopathology (control) against permanent section histopathology (reference standard). * Test Arm: Uses confocal laser fluorescence microscopy (CLFM) for real-time imaging of resected tumor tissues, analyzed by blinded pathologists. * Control Arm: Standard H\&E-stained frozen section, requiring tissue processing (30-40 min) for intraoperative diagnosis. The study evaluates diagnostic accuracy, sensitivity, and specificity of cCeLL - Ex vivo imaging.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Tissue obtained from male or female patients aged 19 years or older.
Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor.
Tissue obtained from patients capable of understanding and signing the informed consent form.

Key exclusion criteria (9 listed)

Specimens and images that meet any of the following criteria will be excluded from the study:
Emergency cases where informed consent could not be obtained before surgery.
Specimens with significant hemorrhage, affecting image quality.
Small biopsy specimens that do not meet the required size for imaging.
Poor-quality images that do not meet study criteria, including:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cCeLL - Ex vivoNeoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.	Diagnostic test	Patients already scheduled for brain tumor surgery

Primary outcome

Clinical Sensitivity for Tumor Detection (Specimen-level)
Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
Clinical Specificity for Tumor Detection (Specimen-level)
Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows

Results and safety

Results posted to the registry on 15 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants	285	271

Primary outcome: Clinical Sensitivity for Tumor Detection (Specimen-level)

Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks). Number (95% Confidence Interval). Unit: Percentage of tumor specimens (%)

Measure	cCeLL - Ex vivo and Frozen Section n = 256
cCeLL - Ex vivo	96.05 (92.80 to 98.30)
Frozen section	94.81 (92.18 to 96.76)

cCeLL - Ex vivo and Frozen Section: Risk Difference (RD): -0.0123, p <0.4049, McNemar

Population analysed: Both tumor and non-tumor specimens were collected from 19 participants.

Primary outcome: Clinical Specificity for Tumor Detection (Specimen-level)

Time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks). Number (95% Confidence Interval). Unit: Percentage of normal specimens (%)

Measure	cCeLL - Ex vivo and Frozen Section n = 32
Frozen Section	67.86 (54.2 to 79.1)
cCeLL - Ex vivo	78.57 (65 to 89.9)

cCeLL - Ex vivo and Frozen Section: Risk Difference (RD): -0.1071 (95% CI -0.1628 to 0.0557), p <0.3075, McNemar

Population analysed: Both tumor and non-tumor specimens were collected from 19 participants.

Adverse events

Time frame: From specimen collection during surgery through final pathology reporting (up to 4 weeks post-surgery). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Group: cCeLL - Ex vivo and Frozen Section	0 of 285 (0%)	0 of 285 (0%)	0 of 285

Limitations and caveats (from the sponsor): 1. Ex vivo design restricts immediate in vivo application. 2. Single-arm structure limits certain statistical inferences. 3. Learning curve affects imaging time. 4. Results may not fully generalize beyond the study settings. 5. Some data were missing, though at a low rate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14519550Amos WB, White JG. How the confocal laser scanning microscope entered biological research. Biol Cell. 2003 Sep;95(6):335-42. doi: 10.1016/s0248-4900(03)00078-9.
BackgroundBIS Research Inc. Medical market data. Updated 2022. https://blog.bisresearch.com/bis-research-market-insights-quick-bytes
BackgroundCarl Zeiss Meditec AG. Convivo: Putting in vivo cellular imaging at your fingertips. 2019:Brochure. Available at: https://www.zeiss.com/content/dam/Meditec/ref_master/products/convivo/documents/convivo_brochure.pdf
Background: PubMed 27279685Chand P, Amit S, Gupta R, Agarwal A. Errors, limitations, and pitfalls in the diagnosis of central and peripheral nervous system lesions in intraoperative cytology and frozen sections. J Cytol. 2016 Apr-Jun;33(2):93-7. doi: 10.4103/0970-9371.182530.
Background: PubMed 31862245de Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17.
BackgroundFerlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2020 (https://gco.iarc.fr/today, accessed February 2021).
BackgroundIndustryARC. Oncology Market - Forecast (2020 - 2025). 2020.
Background: PubMed 30803189Mat Zin AA, Zulkarnain S. Diagnostic Accuracy of Cytology Smear and Frozen Section in Glioma. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):321-325. doi: 10.31557/APJCP.2019.20.2.321.
BackgroundMauna Kea Technologies. Cellvizio: Real-time in vivo cellular imaging platform. 2021:Brochure. Available at: http://www.cellvizio.net/uploads/media/media_pdf/0001/03/MKT-132-EN-Cellvizio%20Web%20Brochure.pdf
BackgroundMAVIG GmbH. Vivascope: Confocal laser scanning microscopy - In vivo histology for cellular level skin analyses in cosmetic research and dermopharmacy. 2019:Brochure. Available at: https://www.vivascope.de/wp-content/uploads/2019/06/Cosmeticbrochure.pdf
BackgroundSamal S, Kalra R, Sharma J, et al. Comparison between crush/squash cytology and frozen section preparation in intraoperative diagnosis of central nervous system lesions. Oncol J India. 2018;1:25-30.
Background: PubMed 25593754Tofte K, Berger C, Torp SH, Solheim O. The diagnostic properties of frozen sections in suspected intracranial tumors: A study of 578 consecutive cases. Surg Neurol Int. 2014 Dec 3;5:170. doi: 10.4103/2152-7806.146153. eCollection 2014.
Individual participant dataSharing planned: No

Related trials for Benign Brain Tumor

Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Gait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes
Stroke, Brain Injuries, Traumatic
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
Not yet recruiting
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas
Glioma, Glioma Intracranial

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sunit Das, MD,MMSc,PhD principal investigator

Unity Health- St. Michael's Hospital

Shin-Hyuk Kang, MD,MMSc,PhD study director

Korea University

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing cCeLL - Ex vivo in people with Benign Brain Tumor and Malignant Brain Tumor, run by VPIX Medical at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Sensitivity for Tumor Detection (Specimen-level) (time frame: From neurosurgical resection to permanent pathology (≈ 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06098248, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.