Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04859725

Validation of Real-time Hyperspectral Imaging in Surgery for Low Grade Glioma Using a Specialized Camera Integrated in the Surgical Microscope

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-01-08

10

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

I

Imec

Collaborating Sponsor

AI-Summary

What this Trial Is About

Low grade glioma (LGG) is a slow-growing, highly invasive brain tumor that is difficult to visually distinguish from normal brain tissue, especially at the tumor borders. This challenge affects the ability to perform early maximal surgical removal, which is the standard treatment. Researchers are exploring the use of hyperspectral imaging (HSI) technology to improve real-time detection and differentiation of LGG tissue during surgery, aiming to support surgical decisions and enhance tumor removal. Patients undergoing standard surgical resection of LGG will have HSI data collected using a SnapScan HSI camera mounted on an operative microscope. Images will be taken before, during, and after tumor removal from specific points identified by a neuronavigational system on the exposed brain surface and cavity walls. Corresponding tissue biopsies will be taken from these points when tumor presence is expected, based on current intraoperative assessments. The study uses a "stop and go" design, starting with nine months of data collection and analysis to identify spectral patterns that distinguish tumor from normal brain tissue. If successful, the study will continue for an additional 26 months to expand data collection and develop software for rapid, real-time tissue detection. Participants will be involved during their surgical procedure, where HSI data and tissue samples are collected. Researchers will analyze hyperspectral image patterns comparing tumor tissue with normal brain tissue during surgery. The study focuses on creating a reliable dataset to explore the potential of this imaging technology. The study includes ongoing assessment of the imaging data and safety procedures, lasting up to 35 months if the study proceeds beyond the initial phase.

CONDITIONS

Official Title

HyperSpectral Imaging in Low Grade Glioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 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
Not Eligible

You will not qualify if you...

  • Children with age < 18 years
  • If final pathology shows a diagnosis other than low grade glioma, data will be excluded from analysis

AI-Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

S

Steven De Vleeschouwer, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

Frequently Asked Questions

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