NCT05171127

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

December 11, 2021

Last Update Submit

March 8, 2023

Conditions

GlioblastomaSurgical Margin

Outcome Measures

Primary Outcomes (1)

  • DRS pattern

    Diffuse Reflectance Spectroscopy pattern in tissue type

    simultaneously with surgery

Study Arms (1)

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

Interventions

Diffuse Reflectance SpectroscopyPROCEDURE

Measurements of DRS patterns in extirpated tumor and cerebral tissue

Glioblastoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients undergoing surgical resection of glial tumor or epileptic focus

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

GlioblastomaMargins of Excision

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Study Officials

  • Oscar Persson, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 11, 2021

First Posted

December 28, 2021

Study Start

April 30, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)