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Technical limitations of in-built operative microscope optics
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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative imaging of 5-ALA during tumour resection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Participants are participating in another trial at time of operation
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| Name | Affiliation | Role |
|---|---|---|
| Puneet Plaha, MD FRCS | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera | Diagnostic Test | 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 | Diagnostic Test | 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. |
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |