Clinical trial · Interventional
Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases
Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial
- 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 issues
Summary
Brief summary (as posted)
Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid
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 |
|---|---|---|---|
| Gliomas, Malignant | Glioma | ALIAS | 0.85 |
| Metastases to Brain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-aminolevulinic acid fluorescence-guided brain tumor resection | Device | — | UNRESOLVED |
| Ultrasound guided brain tumor resection | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasound
- description
- Intraoperative extent of tumor resection will be assessed using sonography
- interventionNames
- Device: Ultrasound guided brain tumor resection
- type
- ACTIVE_COMPARATOR
- label
- Fluorescence
- description
- Intraoperative extent of tumor resection will be assessed using fluorescence with 5-aminolevulinic acid
- interventionNames
- Device: 5-aminolevulinic acid 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 * 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