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Completed

NCT Number: NCT05171127

Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument

Differentiation between glioma tumor tissue and normal cerebral tissue using Diffuse Reflectance Spectroscopy (DRS) on surgical tissue samples ex-vivo

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Key information

About this study

Background: Diffuse reflectance spectroscopy is an optically based technique which measures the amount of diffusely reflected light after it has undergone multiple scattering and absorption events within the tissue. Each DRS spectrum therefore has a specific 'optical fingerprint' reflecting the composition and morphology of the tissue within the probing volume. The technology is easily built into very small instruments that can be fused with regularly used surgical equipment. DRS has previously been widely investigated for the purpose of margin assessment in other regions of the body.

Aim & Hypothesis: The primary goal is to show the feasibility of applying optical tissue sensing using diffuse reflectance spectroscopy (DRS) to differentiate healthy cerebral tissue from tumorous tissue in ex vivo human tissue samples. This will be a basis for further development of surgical equipment able to identify the margin between healthy brain tissue and tumor tissue intraoperatively.

Method: Using DRS we aim to determine spectroscopy thresholds that enables differentiation of cerebral tissue from different forms of tumor tissue. We aim to determine these thresholds by collecting DRS data on ex vivo brain and tumor samples. The tumor samples will be part of the normal extraction of tissue during tumor surgeries and the non tumorous tissue can be extracted in temporal/frontal lobe resections as well as epilepsy surgery, where non tumorous brain tissue is to be removed. The DRS measurements are performed in direct connection to the extraction of tissue during surgery, and the tissue is thereafter sent to the pathologist according to standard clinical procedures. No extra tissue will need to be resected for the purpose of this study. Based on the experiments we will propose a theoretical model for differentiating normal cerebral tissue from tumor tissue in humans for use during surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing surgical resection of glial tumor or epileptic focus

Exclusion criteria

  • Unable to give informed consent

Treatment and study plan

Diffuse Reflectance Spectroscopy

Procedure

Measurements of DRS patterns in extirpated tumor and cerebral tissue

Primary outcomes

  1. DRS pattern

    Time frame: simultaneously with surgery

    Diffuse Reflectance Spectroscopy pattern in tissue type

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Philips Healthcare

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2021
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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