Frozen SectionsPhase 1NCT07254845
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
A Phase 1 study testing cCeLL In vivo and Indocyanine Green in people with Frozen Sections and Indocyanine Green (ICG), run by VPIX Medical.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- What is being tested?
- cCeLL In vivo and Indocyanine Green
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- Being tested
- cCeLL In vivo, Indocyanine Green
- Keywords
- diagnostic imaging, intraoperative, confocal laser endomicroscopy
- 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 In vivoDevice
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 GreenDrug
fluorescence dye for staining tissue
| Study group | Role | What they receive |
|---|---|---|
| cCeLL - In vivo Imaging | Experimental | 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. Receives: Device: cCeLL In vivo; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of cCeLL imaging, compared with frozen section (FS), using the permanent section (PS) as the reference standard.
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.
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Secondary outcomes (5)
Diagnostic Performance of cCeLL vs FS Across Tumor Types and Sampling Sites
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.
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Rate of Non-diagnostic Images with cCeLL
The number of non-diagnostic cCeLL images will be reported, with N_ND representing non-diagnostic images and N_Total the total images acquired.
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Diagnostic Time Comparison (cCeLL vs FS)
Acquisition and interpretation times for cCeLL and FS will be summarized, with differences described; a positive value indicates time saved using cCeLL.
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Time Required for cCeLL Imaging/Interpretation
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.
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Detection of Positive Surgical Margins with cCeLL
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
Measured: Visit 1 (Surgery Day / Intervention Day) as D-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen SectionsStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VPIX Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254845
- Sponsor's protocol ID
- cCeLL_II_2025_Cedars
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) may not be shared due to patient privacy concerns, confidentiality agreements, regulatory restrictions, ethical considerations, and institutional policies. Additionally, data protection laws (e.g., GDPR, HIPAA) and proprietary research interests may limit data availability to ensure compliance and safeguard participant information.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07254845
- Acronym / sponsor ID
- cCeLL_II_2025_Cedars
- Conditions
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- Keywords
- diagnostic imaging, intraoperative, confocal laser endomicroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VPIX MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| cCeLL - In vivo Imaging | Experimental | Device: cCeLL In vivo, Drug: Indocyanine GreenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 In vivoDosage 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 | Device | cCeLL - In vivo Imaging |
| Indocyanine Greenfluorescence dye for staining tissue | Drug | cCeLL - In vivo Imaging |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) may not be shared due to patient privacy concerns, confidentiality agreements, regulatory restrictions, ethical considerations, and institutional policies. Additionally, data protection laws (e.g., GDPR, HIPAA) and proprietary research interests may limit data availability to ensure compliance and safeguard participant information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cCeLL In vivo and Indocyanine Green in people with Frozen Sections and Indocyanine Green (ICG), run by VPIX Medical.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.