Enhanced Detection in Glioma Excision (EDGE)

Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging

The purpose of this study is to determine whether use of an ultra-high sensitivity camera with enhanced imaging technology can be used during surgery to detect areas of brain tissue affected by diffuse glioma, a type of brain cancer.

Study Overview

• Status: Terminated
• Conditions: Glioma
• Intervention / Treatment: Diagnostic test: Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera; Diagnostic test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera; Diagnostic test: Biopsies

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Puneet Plaha, MD FRCS; Phone Number: +441865 234838; Email: Puneet.Plaha@ouh.nhs.uk
• Study Contact Backup: Name: Christopher McKinnon, MBPhD MRCS; Phone Number: +441865 234838; Email: chris.mckinnon@nhs.net

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Female patients are not pregnant at time of surgery.
• Patient has consented to craniotomy for suspected glioma of any type with 5-ALA infusion.

Exclusion Criteria:

• Participants are participating in another trial at time of operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intraoperative imaging of 5-ALA during tumour resection; Participants will undergo 5-ALA guided tumour resection via craniotomy with the aim of achieving maximal safe tumour resection without significant neurological deficit. On completion of tumour resection, digital images will be taken of the resection cavity under blue light using (i) an in-built camera in the operative microscope and (ii) an ultra-high sensitivity camera attached to the side arm of the operative microscope. Biopsies approximately 5x5x5mm in size will then be taken from the anterior, posterior, lateral and inferior areas of the resection cavity which were imaged. These biopsies will be analysed by histopathology to determine the presence of glioma cells.

Diagnostic test: Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera; An ultra-high sensitivity camera attached to the side arm of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.; Diagnostic test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera; In-built camera of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.; Diagnostic test: Biopsies; Following image capture, biopsies (approx 5x5x5mm size) will be taken from regions of the anterior, posterior, lateral and inferior walls of the resection cavity corresponding to the imaged areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of tumour fluorescence in images of resection cavity captured during surgery	Levels of tumour fluorescence in intra-operative images of the resection cavity taken by the ultra-high sensitivity camera and the in-built camera in the operative microscope will be measured. These fluorescence levels will then be used to calculate the sensitivity and specificity of the in-built camera and ultra-high sensitivity camera to detect glioma tissue.	Intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation stages	Time points measured will include (i) time from arrival in theatre to start of operation, (ii) total operation duration and (iii) time from acquisition of images to availability of processed images available for the surgeon to view.	Intra-operative

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Puneet Plaha, MD FRCS, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Malignant glioma; Tumor resection; 5-Aminolevulinic acid (5-ALA)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 255263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No