Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2020-09-21
2021-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intraoperative imaging of 5-ALA during tumour resection
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.
Intra-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.
Intra-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.
Biopsies
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.
Interventions
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Intra-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.
Intra-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.
Biopsies
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Oxford University Hospitals NHS Trust
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Puneet Plaha, MD FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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255263
Identifier Type: -
Identifier Source: org_study_id
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