5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
NCT ID: NCT05850377
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2023-06-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with known or suspected High-Grade Gliomas
Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
5-Aminolevulinic Acid (5-ALA) Gliolan®
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.
Interventions
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5-Aminolevulinic Acid (5-ALA) Gliolan®
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.
Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)
During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sociedad de Lucha Contra el Cáncer del Ecuador
OTHER
Responsible Party
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Principal Investigators
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Alberto Valarezo Chuchuca, MD
Role: PRINCIPAL_INVESTIGATOR
Sociedad de Lucha Contra el Cáncer del Ecuador
Locations
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Sociedad de Lucha Contra el Cáncer
Guayaquil, Guayas, Ecuador
Countries
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Central Contacts
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Facility Contacts
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References
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Widhalm 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.
Nitta 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.
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Stummer 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.
Inoue 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.
Eicker 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.
Beez T, Sarikaya-Seiwert S, Steiger HJ, Hanggi D. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of brain tumors in children--a technical report. Acta Neurochir (Wien). 2014 Mar;156(3):597-604. doi: 10.1007/s00701-014-1997-9. Epub 2014 Jan 22.
Eicker S, Sarikaya-Seiwert S, Borkhardt A, Gierga K, Turowski B, Heiroth HJ, Steiger HJ, Stummer W. ALA-induced porphyrin accumulation in medulloblastoma and its use for fluorescence-guided surgery. Cent Eur Neurosurg. 2011 May;72(2):101-3. doi: 10.1055/s-0030-1252010. Epub 2010 Oct 7. No abstract available.
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Lau D, Hervey-Jumper SL, Chang S, Molinaro AM, McDermott MW, Phillips JJ, Berger MS. A prospective Phase II clinical trial of 5-aminolevulinic acid to assess the correlation of intraoperative fluorescence intensity and degree of histologic cellularity during resection of high-grade gliomas. J Neurosurg. 2016 May;124(5):1300-9. doi: 10.3171/2015.5.JNS1577. Epub 2015 Nov 6.
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Kamp MA, Fischer I, Buhner J, Turowski B, Cornelius JF, Steiger HJ, Rapp M, Slotty PJ, Sabel M. 5-ALA fluorescence of cerebral metastases and its impact for the local-in-brain progression. Oncotarget. 2016 Oct 11;7(41):66776-66789. doi: 10.18632/oncotarget.11488.
Cornelius JF, Slotty PJ, El Khatib M, Giannakis A, Senger B, Steiger HJ. Enhancing the effect of 5-aminolevulinic acid based photodynamic therapy in human meningioma cells. Photodiagnosis Photodyn Ther. 2014 Mar;11(1):1-6. doi: 10.1016/j.pdpdt.2014.01.001. Epub 2014 Jan 31.
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Widhalm G, Wolfsberger S, Minchev G, Woehrer A, Krssak M, Czech T, Prayer D, Asenbaum S, Hainfellner JA, Knosp E. 5-Aminolevulinic acid is a promising marker for detection of anaplastic foci in diffusely infiltrating gliomas with nonsignificant contrast enhancement. Cancer. 2010 Mar 15;116(6):1545-52. doi: 10.1002/cncr.24903.
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Stummer W, Reulen HJ, Meinel T, Pichlmeier U, Schumacher W, Tonn JC, Rohde V, Oppel F, Turowski B, Woiciechowsky C, Franz K, Pietsch T; ALA-Glioma Study Group. Extent of resection and survival in glioblastoma multiforme: identification of and adjustment for bias. Neurosurgery. 2008 Mar;62(3):564-76; discussion 564-76. doi: 10.1227/01.neu.0000317304.31579.17.
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Other Identifiers
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CISOLGYE20230023
Identifier Type: -
Identifier Source: org_study_id
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