Enhanced Detection in Glioma Excision

Not Applicable

Terminated

• Conditions: Glioma
• Interventions: 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

• Registration Number: NCT04556929
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-30
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-18
• Study Start: 2020-09-21
• Study First Posted: 2020-09-21
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative imaging of 5-ALA during tumour resection	Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera	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.
Intraoperative imaging of 5-ALA during tumour resection	Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera	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.
Intraoperative imaging of 5-ALA during tumour resection	Biopsies	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.

Primary Outcome Measures

Name	Time	Method
Level of tumour fluorescence in images of resection cavity captured during surgery	Intra-operative	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

Name	Time	Method
Duration of operation stages	Intra-operative	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.

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom