HyperSpectral Imaging in Low Grade Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04859725
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitaire Ziekenhuizen KU Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Steven De Vleeschouwer, MD, PhD
Principal Investigator Affiliation	UZ Leuven
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low Grade Glioma of Brain

Additional Details

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.

Arms & Interventions

Arms

Experimental: Hyperspectral Imaging with Snapscan camera

Included patients will undergo a resection of the low grade glioma as standard-of-care. Hyperspectral imaging data will be acquired by the SnapScan HSI camera mounted on the (standard) surgical microscope. As such, the surgical procedure does not deviate from the common, standard-of-care surgical procedures, apart from the acquisition of intraoperative scanning images using the SnapScan HSI camera on the microscope. The objective of this all is to get an initial high quality in vivo dataset to start exploring the potential of the technology.

Interventions

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).

Contact a Trial Team

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