HyperSpectral Imaging in Low Grade Glioma

NCT04859725 | Recruiting

• 1 other identifier: S63174
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Grade Glioma of Brain

Keywords

Hyperspectral imaging; Low grade glioma; Tissue discrimination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hyperspectral Imaging with Snapscan camera

EXPERIMENTAL

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.

Device: Hyperspectral Imaging with Snapscan camera

Interventions

Hyperspectral Imaging with Snapscan camera DEVICE

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).

Hyperspectral Imaging with Snapscan camera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Imec: collaborator
• Carl Zeiss Meditec AG: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Hyperspectral Imaging

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Steven De Vleeschouwer, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven De Vleeschouwer, MD, PhD

CONTACT

+3216344290; neurochirurgie@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member of Staff Neurosurgery, Clinical Professor

Model Details: During the first 9 months, the initially collected spectrally corrected datacubes will be analyzed using machine learning. After 9 months, an interim analysis will be made on the datacubes from this primary set with an estimated 10 participants. If a reliable and robust discriminative signal can be detected in low grade glioma tissue, segregating these signals from those in normal tissue, the trial will go on collecting samples for the following 26 months with an inclusion of 10 to 15 participant per year. 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, a decision will be taken on whether or not relevant amendments to the study will be proposed.

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 26, 2021
• Study Start: May 31, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)