Clinical trial · Observational
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
NCT05850377CI-TRIAL-00066246unknownClinicalTrials.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 goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
Conditions
Conditions (11)
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 Neoplasms, Adult, Malignant | Adult Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Neoplasms | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasms, Neuroepithelial | Neuroepithelial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroectodermal Tumors | Primitive Neuroectodermal Tumor | ALIAS | 0.90 |
| Photosensitizing Agents | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Aminolevulinic Acid (5-ALA) Gliolan® | Drug | — | UNRESOLVED |
| Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with known or suspected High-Grade Gliomas
- description
- Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
- interventionNames
- Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®
- Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
Primary outcomes (1)
- measure
- Disease-Free-Survival (PFS)
- timeFrame
- 36 months
- description
- Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
Secondary outcomes (3)
- measure
- Overall survival (OS)
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management) * Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV) * Patients with high-grade and residual glioma following surgery for gross total resection * Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy * Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy) * Progressing, low-grade infiltrative gliomas with one of the following criteria: * Anaplastic foci with contrast uptake in MRI * Spectroscopy study in anaplastic suspected area with high malignancy criteria * Positive choline PET-CT (positron emission tomography / computer tomography) Exclusion Criteria: * Tumors extending across midline * Basal ganglia tumor * Brainstem tumor * Multifocal gliomas * Suspected low-grade glioma without anaplastic foci * Neuraxial dissemination (ependymoma) * Karnofsky grade less than 60% * Infants or pregnant women * Acute or chronic types of porphyria * Non-acceptance of Fluorescence-Guided Surgery * Renal insufficiency confirmed by nephrological assessment * Hepatic impairment confirmed by gastroenterological assessment * Severe heart disease confirmed by cardiological assessment * Decompensated diabetes confirmed by endocrinological assessment * Known allergy to any contrast agent and/or previous history of anaphylactic shock * Hypersensitivity to the active substance or porphyrins * Asthma confirmed by pulmonological assessment * Pacemaker use
References
Publications (25)
- BACKGROUNDWidhalm G, Minchev G, Woehrer A, Preusser M, Kiesel B, Furtner J, Mert A, Di Ieva A, Tomanek B, Prayer D, Marosi C, Hainfellner JA, Knosp E, Wolfsberger S. Strong 5-aminolevulinic acid-induced fluorescence is a novel intraoperative marker for representative tissue samples in stereotactic brain tumor biopsies. Neurosurg Rev. 2012 Jul;35(3):381-91; discussion 391. doi: 10.1007/s10143-012-0374-5. Epub 2012 Mar 10. PMID 22407140
- BACKGROUNDNitta T, Sato K. Prognostic implications of the extent of surgical resection in patients with intracranial malignant gliomas. Cancer. 1995 Jun 1;75(11):2727-31. doi: 10.1002/1097-0142(19950601)75:113.0.co;2-h. PMID 7743477
- BACKGROUNDLacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190. PMID 11780887
- BACKGROUNDStummer 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
- BACKGROUNDInoue T, Endo T, Nagamatsu K, Watanabe M, Tominaga T. 5-aminolevulinic acid fluorescence-guided resection of intramedullary ependymoma: report of 9 cases. Neurosurgery. 2013 Jun;72(2 Suppl Operative):ons159-68; discussion ons168. doi: 10.1227/NEU.0b013e31827bc7a3. PMID 23149963
- BACKGROUNDEicker SO, Floeth FW, Kamp M, Steiger HJ, Hanggi D. The impact of fluorescence guidance on spinal intradural tumour surgery. Eur Spine J. 2013 Jun;22(6):1394-401. doi: 10.1007/s00586-013-2657-0. Epub 2013 Jan 10. PMID 23307195