Enhanced Detection in Glioma Excision

Study Overview
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Brief Summary
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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.

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

Conditions
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Glioma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative imaging of 5-ALA during tumour resection<br>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<br>* 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.<br>Diagnostic Test: Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera<br>* 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.<br>Diagnostic Test: Biopsies<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection