Validation of Label-free, Wide-field, Real-time Intra-operative Tissue Discrimination and Tumor Detection of Low Grade Glioma Using a Hyperspectral Imaging (HSI) Sensor/camera Integrated in the Operative Microscope

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Steven De Vleeschouwer, MD, PhD
neurochirurgie@uzleuven.be
+3216344290
Time Frame
Start Date: 2021-05-31
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Carl Zeiss Meditec AG, Imec
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov