Clinical trial · Interventional
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
NCT00241670CI-TRIAL-00006789completedPhase 3ClinicalTrials.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)
The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Cancer of Brain | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Primary Brain Tumors | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-aminolevulinic acid (5-ALA) | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5-aminolevulinic acid
- interventionNames
- Drug: 5-aminolevulinic acid (5-ALA)
- type
- NO_INTERVENTION
- label
- Conventional resection
Primary outcomes (2)
- measure
- 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
- timeFrame
- Within 72 hours after surgery
- measure
- 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma). * Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection. * First operation of the tumour, no other tumour-specific pretreatment * Karnofsky at least 70 % * Patient's written informed consent * Age 18-72 years Exclusion Criteria: * Tumour location in the midline, basal ganglia, cerebellum or brain stem * More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases * Porphyria, hypersensitivity to porphyrins * Renal insufficiency: Creatinine \> 2.0 mg/dl * Hepatic insufficiency: Bilirubin \> 3 mg/dl * Quick test \< 60 % * gamma-GT \> 70 U/I * Malignancies other than basaliomas * Existing or planned pregnancy or lactation, or inadequate contraception * Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
References
Publications (1)
- DERIVEDStummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9. PMID 16648043