All of the included patients received 5-ALA (20 mg/kg body weight; Gliolan, medac, Wedel, Germany) for fluorescence-guided brain tumor resection. The 5-ALA solution was prepared by dissolving a vial of 5-ALA (1:5 g) in 50 ml of water. The 5-ALA solution was administered orally 3 h before induction of anesthesia. Surgery was performed by using a neurosurgical microscope (NC 4 OPMI Neuro FL or Pentero surgical microscope, Zeiss, Oberkochen). The microscope enabled switching from conventional white light to violet-blue excitation light to visualize tumor fluorescence. Before resection of the brain tumor, manual white balance was done to normalize the fluorescence signal intensity. Immediately after exposure of the lesions, the brain tumors were examined under the fluorescence mode of the microscope. The presence of 5-ALA fluorescence was visually graded on a scale of three after white (grade I as no or mild intensity, grade II as moderate intensity, and grade III as strong intensity) by two neurosurgeons blinded to the study (Fig. 1 ).[18 (link)] Tumor resection was performed as completely as possible and thought to be safely feasible by the surgeon.
5 ala
Manufactured by Medac
Sourced in Germany
5-ALA is a chemical compound used in various medical and scientific applications. It serves as a precursor for the synthesis of protoporphyrin IX, an important molecule involved in several biological processes. The core function of 5-ALA is to facilitate the production of this photosensitive compound, which can have various uses in diagnostic and therapeutic procedures.
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5 protocols using 5 ala
1
5-ALA Guided Brain Tumor Resection
2
5-ALA Dosage Evaluation for Surgical Guidance
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Block randomization was performed by opening a preprepared sealed randomization envelope after a patient's registration.
Supplies of 5-ALA (Medac GmbH, Wedel, Germany) were dispensed by the hospital pharmacy according to patient weight and placed in closed, nontransparent containers to be indiscernible to the study staff. The ready-for-use solution was prepared by dissolving the test drug with 50 mL of water injected into the light-sealed drinking container without opening the container. Patients received 5-ALA at 0.2, 2, or 20 mg/kg b.w. 3 h (range 2.5-3.5 h) prior to anesthesia.
For statistical methods, please refer toSupplemental Digital Content 1
Supplies of 5-ALA (Medac GmbH, Wedel, Germany) were dispensed by the hospital pharmacy according to patient weight and placed in closed, nontransparent containers to be indiscernible to the study staff. The ready-for-use solution was prepared by dissolving the test drug with 50 mL of water injected into the light-sealed drinking container without opening the container. Patients received 5-ALA at 0.2, 2, or 20 mg/kg b.w. 3 h (range 2.5-3.5 h) prior to anesthesia.
For statistical methods, please refer to
3
Maximizing Glioma Resection with 5-ALA Guidance
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Tumor resection was performed with the guidance of neuronavigation (StealthStation, Medtronic, Fridley, MN) and 5-aminolevulinic acid fluorescence (5-ALA, Medac, Stirling, UK) for maximal safe resection. Chemoradiotherapy regimen was determined after surgery by the multidisciplinary team according to patient postoperative status. Extent of resection was assessed according to the postoperative MRI scans within 72 hours as complete resection, partial resection of enhancing tumor, or biopsy [11] (link). All patients were followed up according to the criteria of Response Assessment in Neuro-Oncology [12] (link), incorporating clinical and radiological parameters. Patient survival was analyzed for overall survival (OS) and progression-free survival (PFS). The latter was made retrospectively in some patients to avoid the issue of pseudoprogression, where new contrast enhancement appeared within the first 12 weeks after completing chemoradiotherapy.
4
Maximal Safe Resection for Gliomas
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All patients underwent maximal safe surgery using 5-aminolevulinic acid fluorescence (5-ALA, Medac) and neuro-navigation (StealthStation, Medtronic). For maximal safe resection in both study cohorts, where appropriate, other adjuvants, including awake surgery, cortical and subcortical mapping and intraoperative electrophysiology were also applied. According to the postoperative MRI within 72 h, the extent of resection was assessed as complete or partial resection of enhancing tumour or biopsy. Adjuvant therapy was determined by the multidisciplinary team as standard based on patient postoperative status. All patients were followed up according to the response assessment in neuro-oncology criteria. Overall survival (OS) and progression-free survival (PFS) were used as endpoints.
5
Intraoperative 5-ALA Guided Tumor Sampling
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Three to 5 hours before surgery, 5-ALA (20 mg/kg of body weight; Medac GmbH) was administered orally to patients. During surgery, 3 different tumor sites were visualized based on the presence of red-violet fluorescence, following excitation with ultraviolet blue light (FL 400 filter, Leica M720 OH5, Leica Microsystems).
Sampling sites were confirmed via intraoperative neuronavigation and classified as follows: 1) The ALA+ area is analogous to the enhancing area in neuronavigation and corresponds to the tumor core, with lava-like red fluorescence. 2) The ALA PALE area is analogous to the tumoral boundaries surrounding the enhancing area and corresponds to the tumor inner periphery, with pale red fluorescence. 3) The tumor outer periphery, without fluorescence, is the ALA-area and is analogous to the nonenhancing areas distant from the tumor (Fig. 2).
For each sampling site, a few cubic millimeters of tissue was collected and preserved in DMEM (Invitrogen) at 4°C before processing.
Sampling sites were confirmed via intraoperative neuronavigation and classified as follows: 1) The ALA+ area is analogous to the enhancing area in neuronavigation and corresponds to the tumor core, with lava-like red fluorescence. 2) The ALA PALE area is analogous to the tumoral boundaries surrounding the enhancing area and corresponds to the tumor inner periphery, with pale red fluorescence. 3) The tumor outer periphery, without fluorescence, is the ALA-area and is analogous to the nonenhancing areas distant from the tumor (Fig. 2).
For each sampling site, a few cubic millimeters of tissue was collected and preserved in DMEM (Invitrogen) at 4°C before processing.
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