cCeLL Imaging for Brain Cancer

Recruiting at 3 trial locations

Overseen By Heejoon Um

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VPIX Medical

Disqualifiers: Multiple surgeries on lesion

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

Compensation: Varies

Number of Visits: 1

160 Participants Needed

Trial Summary

What is the purpose of this trial?

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\[s\] it aims to answer are: * Is it as accurate as standard biopsy practices? * Can it be performed faster than standard biopsy practices? Participants will consent to having their tumor tissue assessed by both cCeLL and standard biopsy procedures. There are no additional participation requirements beyond the tumor removal surgery.

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 data supports the effectiveness of the cCeLL Ex Vivo treatment for brain cancer?

The research on electrochemotherapy (ECT) shows that combining an electric field with drugs can significantly increase drug uptake by tumor cells, leading to partial responses and complete cures in some cases. This suggests that similar techniques, like cCeLL Ex Vivo, might also enhance treatment effectiveness for brain cancer. ^{1 2 3 4 5}

Is cCeLL Imaging for Brain Cancer safe for humans?

The safety of cCeLL Imaging for Brain Cancer isn't directly addressed in the available studies, but related research on similar treatments like mesenchymal stromal cells and CAR-T cells for glioblastoma suggests that these types of therapies are being actively evaluated for safety in humans. ^{6 7 8 9 10}

How does the cCeLL Imaging treatment for brain cancer differ from other treatments?

The cCeLL Imaging treatment for brain cancer is unique because it involves advanced imaging techniques like confocal laser endomicroscopy (CLE) to precisely identify tumor margins during surgery, potentially improving surgical outcomes by providing real-time, high-resolution images of brain tissues. ^{4 11 12 13 14}

Research Team

Sunit Das, MD

Principal Investigator

Unity Health- St. Michael's Hospital

Shin-Hyuk Kang, MD, M.M.Sc, PhD

Principal Investigator

Korea University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who are male or female and ≥ 19 years of age, and the patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection. There will be up to three (3) tissue sample types assessed for each participant: 1- center-of-tumor, 2- normal tissue (collected from inevitable standard resection), and 3- margin tissue. Tissues will be removed as part of the standard neurosurgical procedure. Resected tissue will be cleaned, stained, and imaged ex-vivo using cCeLL. Image recordings of sample tissue using cCeLL - Ex vivo are taken and the obtained data is stored.

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+

Findings from Research

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

In Vitro Validation of Intratumoral Modulation Therapy for Glioblastoma. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Rapid and quantitative assessment of cancer treatment response using in vivo bioluminescence imaging. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Electrochemotherapy--a novel method of cancer treatment. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy of glioblastoma explants induces interferon-γ responses and spatial immune cell rearrangements in tumor center, but not periphery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Convection enhanced delivery for treating brain tumors and selected neurological disorders: symposium review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Analysis of the safety of mesenchymal stromal cells secretome for glioblastoma treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and antitumor activity of GD2-Specific 4SCAR-T cells in patients with glioblastoma. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Preclinical Models of Brain Metastases in Breast Cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

In vivo bioluminescence imaging in an experimental mouse model for dendritic cell based immunotherapy against malignant glioma. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of the relative biological effectiveness of carbon ion beams in the cerebellum using the rat organotypic slice culture system. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Clinical Trials in Breast Cancer Brain Metastases: Barriers and Innovations. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Simple 3D Cell Culture Method for Studying the Interactions between Human Mesenchymal Stromal/Stem Cells and Patients Derived Glioblastoma. [2023]

13. Italy pubmed.ncbi.nlm.nih.gov

Utilization of intraoperative confocal laser endomicroscopy in brain tumor surgery. [2019]

14. England pubmed.ncbi.nlm.nih.gov

A bioprinted human-glioblastoma-on-a-chip for the identification of patient-specific responses to chemoradiotherapy. [2020]