Glioma
Conditions
Keywords
5-Aminolevulinic acid (5-ALA), Malignant glioma, Tumor resection
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.
Interventions
DIAGNOSTIC_TESTIntra-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.
DIAGNOSTIC_TESTIntra-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.
DIAGNOSTIC_TESTBiopsies
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.
Sponsors
Oxford University Hospitals NHS Trust
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed