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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04859725
Other study ID # S63174
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2021
Est. completion date June 2024

Study information

Verified date November 2023
Source Universitaire Ziekenhuizen KU Leuven
Contact Steven De Vleeschouwer, MD, PhD
Phone +3216344290
Email neurochirurgie@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Low grade glioma (LGG) is a slowly evolving, highly invasive intrinsic brain tumor displaying only subtle tissue differences with the normal surrounding brain, hampering the attempts to visually discriminate tumor from normal brain, especially at the border interface. This makes anatomical borders hard to define during early maximal resection, which is the initial treatment strategy. Therefore, innovative, robust and easy-to-use real-time strategies for intra-operative detection and discrimination of (residual) LGG tumor tissue would strongly influence on-site, surgical decision making, enabling a maximal extent of resection. To validate this approach hyperspectral imaging (HSI) - using a SnapScan HSI-Camera (IMEC), stably mounted on an OPMI Pentero 900 microscope (Zeiss) - will be used to generate spectral imaging data patterns that discriminate in vivo low grade glioma tissue from normal brain both on the cortical and subcortical level.


Description:

Included patients will undergo a resection of the low grade glioma as standard-of-care. Before, during and after the resection, HSI data ('datacubes') will be acquired by the SnapScan HSI camera on the microscope of all relevant areas of the exposed cortical surface and subcortical cavity walls. The exact points of which the datacubes will be acquired are defined by unequivocal single points on the neuronavigational system (Brainlab). From the points from which the datacubes have been obtained a corresponding tissue sample will be obtained (labeled biopsy) if tumor tissue is to be expected in that particular point, based on the current standard of care assessments intraoperatively using white light illumination on the microscope, intraoperative navigation and intraoperative ultrasound. As such, normally looking brain in the resection cavity wall, will only be biopsied if tumor free margins should be proven as part of the standard-of-care operative procedure (non-critically eloquent brain regions). The objective of this all is to get an initial high quality in vivo dataset to start exploring the potential of the technology. The project will follow a 'stop and go' design: during the first 9 months, the initially collected spectrally corrected datacubes will be analyzed using machine learning on coded data sets. After this initial phase, an interim analysis will be made from the full list of analyzed datacubes. If a reliable and robust discriminative signal can be detected in low grade glioma tissue, segregating these signals from those in normal tissue (as defined pathologically and/or radiologically), efficacy is demonstrated (proof of concept) and the trial will go on for further collecting of samples in the following 26 months. Within the expanded dataset, the different spectral data patterns will be translated into user's friendly pattern codes for rapid real-time, on-site detection and interpretation through development of dedicated software. If no reliable signal can be retrieved from low grade glioma tissue in vivo during the surgery, further recruitment of patients will be stopped. At that time, the investigators and partners will decide on whether or not relevant amendments to the study will be proposed or not.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Radiologically suspected low grade glioma (newly diagnosed or recurrent) - Scheduled for tumor resection at UZ Leuven - Signed informed consent document prior to resection Exclusion Criteria: - Children with age < 18 years - If final pathology reveals other pathological diagnosis than low grade glioma, datacubes will not be included in the final analysis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hyperspectral Imaging with Snapscan camera
Before, during and after the resection, HSI data ('datacubes') will be acquired by the SnapScan camera of all relevant areas of the exposed cortical surface and subcortical cavity walls. The exact points of which the datacubes will be acquired are defined by unequivocal single points on the routinely used neuronavigational system. From the points from which the datacubes have been obtained a corresponding tissue sample will be obtained (labeled biopsy) if tumor tissue is to be expected in that particular point, based on the current standard of care assessments intraoperatively using white light illumination on the microscope, intraoperative navigation and intraoperative ultrasound. As such, normally looking brain in the resection cavity wall, will only be biopsied if tumor free margins should be proven as part of the standard-of-care operative procedure (non-critically eloquent brain regions).

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven Carl Zeiss Meditec AG, Imec

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of hyperspectral image patterns of superficial and deep tumor tissue with patterns of normal brain Assessment of discriminate power of HSI data between 468 and 780 nm between tumor and normal brain tissue by comparison of data acquired on imec VNIR HSI Snapscan camera and gold standard image segmentation of brain tissue.
Image segmentation of white light images acquired on the Pentero 900 surgical microscope will be performed based on the assessment of the surgeon and on histopathological assessment of biopsies taken within the standard of care procedure. A co-registration of the segmented images and will be transferred to subsequently acquired HSI data and used to statistical assess whether HSI data can be used to discriminate the spectral signatures of healthy and tumorous tissue in vivo.
During the surgical procedure
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