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Enhanced Detection in Glioma Excision (EDGE)

Primary Purpose

Glioma

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera
Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera
Biopsies
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring 5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Radcliffe HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative imaging of 5-ALA during tumour resection

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 30, 2020
Last Updated
April 27, 2021
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04556929
Brief Title
Enhanced Detection in Glioma Excision
Acronym
EDGE
Official Title
Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
March 19, 2022 (Anticipated)
Study Completion Date
June 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative imaging of 5-ALA during tumour resection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biopsies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of tumour fluorescence in images of resection cavity captured during surgery
Description
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.
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
Duration of operation stages
Description
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.
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Puneet Plaha, MD FRCS
Phone
+441865 234838
Email
Puneet.Plaha@ouh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher McKinnon, MBPhD MRCS
Phone
+441865 234838
Email
chris.mckinnon@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Puneet Plaha, MD FRCS
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher McKinnon, MBPhD MRCS
Phone
01865 234838
Email
chris.mckinnon@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Enhanced Detection in Glioma Excision

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