cCeLL Imaging for Brain Cancer

(cCeLLExvivo Trial)

No longer recruiting at 6 trial locations

Overseen By Heejoon Um

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VPIX Medical

Disqualifiers: Multiple surgeries on lesion

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method called cCeLL to determine its accuracy compared to the standard method for checking brain tumors during surgery. The researchers aim to find out if cCeLL can provide results that are just as accurate and possibly faster than current methods. Participants are patients already scheduled for brain tumor surgery, where their tumor tissue will be examined using both cCeLL and the standard procedure. Ideal participants are those who suspect they have a brain tumor and are already scheduled for surgery to remove it. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging and biopsy procedures during surgery.

What prior data suggests that cCeLL imaging is safe for brain tumor surgeries?

Research shows that cCeLL imaging is being tested for its accuracy compared to standard biopsy methods during brain tumor surgeries. Although specific safety data on cCeLL imaging is not yet available, similar imaging techniques, such as optical coherence tomography (OCT), have been studied and found safe. These methods have been used in labs to distinguish cancerous tissue from healthy tissue.

This trial does not focus on testing safety, indicating that earlier studies found the imaging process generally safe. In this trial, imaging occurs outside the body (ex vivo) after tissue removal during surgery, further reducing any safety risks for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cCeLL Imaging technique for brain cancer because it offers a new way to visualize tumor cells. Unlike traditional imaging methods like MRI and CT scans, which provide images prior to surgery, cCeLL Imaging allows for detailed examination of tissue samples after they are removed during surgery. This ex vivo imaging technique could provide more precise information about the tumor margins and surrounding tissues, potentially leading to better surgical outcomes and personalized treatment plans. By enhancing the accuracy of tumor identification, cCeLL Imaging might improve the effectiveness of brain cancer surgeries.

What evidence suggests that cCeLL imaging is effective for brain tumor surgeries?

Research has shown that cCeLL Ex Vivo, the investigational tool in this trial, accurately detects brain tumors. One study found it identified tumors 89.2% of the time, slightly surpassing the 86.5% accuracy of the traditional frozen section analysis. Both methods demonstrated equal sensitivity, correctly identifying people with the disease 92.2% of the time. These findings suggest that cCeLL Ex Vivo could be a reliable tool for assessing brain tumors and might deliver results faster than standard biopsy methods. ^{1 3 4 6 7}

Who Is on the Research Team?

Sunit Das, MD,MMSc,PhD

Principal Investigator

Unity Health- St. Michael's Hospital

Shin-Hyuk Kang, MD,MMSc,PhD

Principal Investigator

Korea University

Are You a Good Fit for This Trial?

This trial is for men and women over 19 years old who are suspected to have a brain tumor and are scheduled for neurosurgery. They must be able to understand and give informed consent. It's not open to patients who've had multiple surgeries on the same lesion.

Inclusion Criteria

I am 19 years old or older.

I am willing and able to understand and sign the consent form.

I am scheduled for brain surgery to possibly remove a tumor.

Exclusion Criteria

I have had multiple surgeries on the lesion in question.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Imaging

Participants undergo brain tumor surgery, during which tissue samples are imaged using cCeLL and standard frozen section analysis

Perioperative

1 visit (in-person)

Follow-up

Participants are monitored for any post-surgical complications and outcomes of the imaging analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• cCeLL Ex Vivo

Trial Overview

The trial tests if cCeLL imaging can match or exceed the accuracy of standard biopsy methods during brain tumor surgery, and if it can do so more quickly. Participants will have their removed tumor tissue examined by both cCeLL and traditional biopsies.

How Is the Trial Designed?

Group I: Patients already scheduled for brain tumor surgery Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VPIX Medical

Lead Sponsor

Trials

2

Recruited

260+

Samsung Medical Center

Collaborator

Trials

1,069

Recruited

11,140,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Seoul National University Hospital

Collaborator

Trials

1,939

Recruited

6,643,000+

Korea University Anam Hospital

Collaborator

Trials

152

Recruited

82,800+

Published Research Related to This Trial

Infusion of GD2-specific fourth-generation safety-designed chimeric antigen receptor (4SCAR)-T cells in eight patients with GD2-positive glioblastoma (GBM) was found to be safe and well tolerated, with no severe adverse events reported.

Of the eight patients, four experienced a partial response lasting between 3 to 24 months, indicating that 4SCAR-T cells can exert anti-GBM activity, with a median overall survival of 10 months post-infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and antitumor activity of GD2-Specific 4SCAR-T cells in patients with glioblastoma. Liu, Z., Zhou, J., Yang, X., et al.[2023]

The secretome of human adipose-derived stem cells (hADSC) did not enhance the cancer stem cell features or drug resistance in human glioblastoma (GBM) cells, indicating a level of safety for potential cancer therapies.

While hADSC conditioned medium did not affect the proliferation or drug response of GBM cells, it significantly increased their migration capacity, suggesting that interactions between hADSCs and tumor cells could influence tumor behavior in the microenvironment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the safety of mesenchymal stromal cells secretome for glioblastoma treatment. Onzi, GR., Ledur, PF., Hainzenreder, LD., et al.[2022]

Citations

1.

nature.com

nature.com/articles/s41598-024-52494-6

A prospective multicenter assessor blinded pilot study ...

cCeLL-Ex vivo exhibited a relatively higher diagnostic accuracy (89.2%) than frozen section analysis (86.5%), with both methods showing a sensitivity of 92.2%.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06098248

Study Details | NCT06098248 | cCeLL - Ex Vivo (Confocal ...

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4482228/

Detection of Human Brain Cancer Infiltration ex vivo and in ...

This study tested the feasibility of label-free, quantitative optical coherence tomography (OCT) for differentiating cancer from non-cancer in human brain ...

4.

trials.braintumor.org

trials.braintumor.org/trials/NCT06098248

cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for ...

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries. The main question[s] ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666379123001568

A living ex vivo platform for functional, personalized brain ...

We have developed an organotypic brain slice culture (OBSC)-based platform and multi-parametric algorithm that enable rapid engraftment, treatment, and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06098248

Study Details | cCeLL - Ex Vivo (Confocal Fluorescence ...

The goal of this clinical trial is to determine if cCeLL imaging is as accurate as standard biopsy practices for brain tumor surgeries.

7.

withpower.com

withpower.com/trial/phase-neoplasms-2024-ffb33

cCeLL Imaging for Brain Cancer · Info for Participants

The safety of cCeLL Imaging for Brain Cancer isn't directly addressed in the available studies, but related research on similar treatments like mesenchymal ...