cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Malignant Brain Tumor Clinical Trial

Official title:

A Prospective, Multi-centered, Assessor-blinded Clinical Performance Study to Evaluate the Sensitivity and Specificity of the Proposed Cell/Tissue Histopathology Image Processor cCeLL - Ex Vivo (Confocal Fluorescence Endomicroscopy) for Intraoperative Brain Tumor Diagnosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06098248
• Other study ID #: cCell_BT_2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: VPIX Medical
• Contact: Kyungmin Hwang
• Phone: 010-4366-3519
• Email: k.hwang[@]vpixmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The usual practice for imaging brain tumor tissue during this type of operation, is to remove tissue from a suspicious lesion and send the tissue to the pathology department where pathologists perform a test called "frozen section". The frozen section test cools the tissue to give a diagnosis of the tissue sample (e.g., cancerous or normal tissue). This process may take up to 40 minutes to perform and uses a lot of resources within the hospital. The operation can only be finished after this report is available to the surgeon. After the surgery, the tissue is assessed by pathology with a test called permanent section which can give more details about the tissue assessment. Permanent section results are not available until after the surgery is complete. VPIX Medical Inc. has developed a system to image brain tumor tissue for the purpose of making a diagnosis (clinical decision) during the operation. This system uses Confocal Laser Endomicroscopy to image the removed tissue during the operation. This may be able to replace current standard 'frozen section analysis', which would decrease the resources needed to image the tissue, and provide faster results to the surgeon during the operation. The investigators are performing this study to determine if this type of imaging is as accurate as frozen section and if it can be performed faster. The tissue samples that are being assessed by the study device will be removed as part of a participant's normal surgery. This study will compare the results of the study device and the frozen section results. During the participant's surgery, only the standard test results will be used to make decisions. The images generated by cCeLL device will also be stored in a secure server outside of Canada, for the duration of the study. These images will be de-identified to protect participant privacy, and will be used to create a scientific repository.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• The biological specimens (hereafter referred to as 'tissue') and/or images to be used in this trial must be collected from patients who satisfy all of the following inclusion criteria:

1. Male or female patients, = 19 years of age.

2. Patient is suspected to have a brain tumor and has been scheduled for neurosurgery with a potential tumor resection.

3. Patient is willing and able to provide informed consent and understand its content.

Exclusion Criteria:

• Tissue and/or images to be used in this trial must be collected from patients who do not meet any of the following exclusion criteria:

1. Patient has undergone several surgeries on lesion of interest.

Related Conditions & MeSH terms

• Benign Brain Tumor
• Brain Neoplasms
• Malignant Brain Tumor
• Neoplasms

Intervention

Diagnostic Test:
• cCeLL - Ex vivo
Neoplastic brain tissue biopsied from participant will be visualized, and images will be captured using cCeLL - Ex vivo.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
VPIX Medical	Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital, Unity Health Toronto

Countries where clinical trial is conducted

Canada,  Korea, Republic of, 

References & Publications (14)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

WHO. Assessing national capacity for the prevention and control of noncommunicable diseases: report of the 2019 global survey. Geneva: World Health Organization; 2020.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cCeLL - Ex vivo and Frozen Section Agreement	Agreement between cCeLL - Ex vivo and frozen section reported as the sensitivity and specificity outcomes of cCeLL Ex vivo.	Perioperative
Secondary	Comparison of imaging and analysis duration of cCeLL - Ex vivo compared to frozen section	Time from the beginning of imaging to the completion of analysis	Perioperative
Secondary	Time required to diagnose cCeLL - Ex vivo imaging	Time required by the blinded assessor reach a diagnosis.	Perioperative
Secondary	The total number of non-diagnostic cCeLL - Ex vivo images.	Reported as a percentage. Number of non-diagnostic images divided by the total number of images taken	Perioperative
Secondary	Number of images required to diagnose cCeLL imaging	Number of images required by the blinded assessor reach a diagnosis.	Perioperative