Enhanced Detection in Glioma Excision

Glioma Clinical Trial

— EDGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04556929
• Other study ID #: 255263
• Status: Terminated
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: November 3, 2021

Study information

• Verified date: September 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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