Clinical trial · Interventional
Enhanced Detection in Glioma Excision
Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging
NCT04556929CI-TRIAL-00075311EDGEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Technical limitations of in-built operative microscope optics
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies | Diagnostic Test | — | UNRESOLVED |
| Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera | Diagnostic Test | — | UNRESOLVED |
| Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative imaging of 5-ALA during tumour resection
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Level of tumour fluorescence in images of resection cavity captured during surgery
- timeFrame
- Intra-operative
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.