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

March 8, 2023 updated by: Oscar Persson, Karolinska University Hospital
Differentiation between glioma tumor tissue and normal cerebral tissue using Diffuse Reflectance Spectroscopy (DRS) on surgical tissue samples ex-vivo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing surgical resection of glial tumors or non-neoplastic cerebral lesions at Karolinska University Hospital

Description

Inclusion Criteria:

  • Patients undergoing surgical resection of glial tumor or epileptic focus

Exclusion Criteria:

  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glioblastoma
No intervention. Observation of diffuse reflectance spectroscopy patterna are made on ex-vivo tissue samples in patients undergoing surgery for glial tumors.
Procedure: Diffuse Reflectance Spectroscopy
Measurements of DRS patterns in extirpated tumor and cerebral tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DRS pattern
Time Frame: simultaneously with surgery
Diffuse Reflectance Spectroscopy pattern in tissue type
simultaneously with surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Philips Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 11, 2021

First Submitted That Met QC Criteria

December 11, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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