Enhanced Detection in Glioma Excision (EDGE)

University of Oxford

Status: Terminated

Conditions: Glioma

Treatments: Diagnostic Test: Biopsies; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04556929

255263

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Intraoperative imaging of 5-ALA during tumour resection

Experimental group

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.

Treatment:

Diagnostic Test: Biopsies

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