Clinical trial · Interventional
Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases
Concurrent Fluorescence and Sonographically Guided Eradication of Gliomas and Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled Trial
NCT05474573CI-TRIAL-00089808CONFLUENSErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.
Conditions
Conditions (2)
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, Malignant | Malignant Glioma | ALIAS | 0.90 |
| Metastases to Brain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined ultrasound and fluorescence-guided brain tumor resection | Device | — | UNRESOLVED |
| Fluorescence-guided brain tumor resection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluorescence and Ultrasound
- description
- Extent of tumor resection will be intraoperatively assessed using both fluorescence with 5-aminolevulinic acid and sonography
- interventionNames
- Device: Combined ultrasound and fluorescence-guided brain tumor resection
- type
- ACTIVE_COMPARATOR
- label
- Fluorescence
- description
- Extent of tumor resection will be intraoperatively assessed using fluorescence with 5-aminolevulinic acid
- interventionNames
- Device: Fluorescence-guided brain tumor resection
Primary outcomes (1)
- measure
- Gross total resection (Yes or No)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas) * one or several brain metastases from any cancer * newly diagnosed * Karnofsky Performance Status 60-100% * age 18-79 years * performed magnetic resonance imaging with contrast enhancement Exclusion Criteria: * tumor spreading to corpus callosum or brainstem * previously performed brain radiotherapy * planned supratotal tumor resection until neurophysiologically revealed eloquent areas * known hypersensibility to 5-aminolevulinic or to porphyrin * hepatic or renal insufficiency * porphyria * pregnancy * breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.