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NCT05171127 Clinical Trial

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

Glioblastoma Clinical Trial

Official title:
Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05171127
Other study ID # 2019-00100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2019
Est. completion date December 31, 2022

Study information
Verified date March 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing surgical resection of glial tumor or epileptic focus Exclusion Criteria: - Unable to give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Diffuse Reflectance Spectroscopy
Measurements of DRS patterns in extirpated tumor and cerebral tissue

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska University Hospital Philips Healthcare

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary DRS pattern Diffuse Reflectance Spectroscopy pattern in tissue type simultaneously with surgery
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