Trial reportNeurosurgery2017
Randomized, Prospective Double-Blinded Study Comparing 3 Different Doses of 5-Aminolevulinic Acid for Fluorescence-Guided Resections of Malignant Gliomas.
Trial report in Neurosurgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 5 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
55 citing papers in PubMed, 5 syntheses or guidelines pooled it, 115 citations in OpenAlex.
- Intraoperative imaging technology to maximise extent of resection for glioma: a network meta-analysis.The Cochrane database of systematic reviews · 2021Pooled it
- Treatment of newly diagnosed glioblastoma in the elderly: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Intraoperative fluorescence diagnosis in the brain: a systematic review and suggestions for future standards on reporting diagnostic accuracy and clinical utility.Acta neurochirurgica · 2019Pooled it
- The impact of 5-aminolevulinic acid on extent of resection in newly diagnosed high grade gliomas: a systematic review and single institutional experience.Journal of neuro-oncology · 2019Pooled it
- Intraoperative imaging technology to maximise extent of resection for glioma.The Cochrane database of systematic reviews · 2018Pooled it
- Intraoperative fluorescence imaging with aminolevulinic acid detects grossly occult breast cancer: a phase II randomized controlled trial.Breast cancer research : BCR · 2021Trial
- Effects of 5-ALA dose on resection of glioblastoma.Journal of neuro-oncology · 2019Trial
- Impact of 5-ALA and sodium fluorescein on FLAIR volume extent of resection and survival in IDH-wildtype glioblastoma.Journal of neuro-oncology · 2026Article
- The AENEAS Project: Intraoperative Anatomical Guidance Through Real-Time Landmark Detection Using Machine Vision.Mayo Clinic proceedings. Digital health · 2026Article
- 5-ALA vs. fluorescein guided resection for high-grade gliomas: A systematic review and meta-analysis.Molecular and clinical oncology · 2026Article
- Real-World Experience With Givosiran in Acute Porphyrias: A Narrative Review and a Novel Hypothesis.Cureus · 2026Review
- Image-Guided Brain Tumor Surgery.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026Review
- Protoporphyrin IX plasma and blood pharmacokinetics and brain tumor distribution determined by a validated LC-MS/MS method.Scientific reports · 2025Article
- Integration of 5-ALA fluorescence and intraoperative MRI in awake craniotomy for glioma resection: a six-year retrospective analysis.Neurosurgical review · 2025Article
- Review
- Predicting intraoperative 5-ALA-induced tumor fluorescence via MRI and deep learning in gliomas with radiographic lower-grade characteristics.Journal of neuro-oncology · 2025Article
- Antitumor immunostimulatory effect via cell-killing action of a novel extracorporeal blood circulating photodynamic therapy system using 5-aminolevulinic acid.Scientific reports · 2025Article
- Systematic review of fluorescence-guided surgery in pituitary neuroendocrine tumours.Endocrine oncology (Bristol, England) · 2025Review
- Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240).Journal of neuro-oncology · 2024Article
- Exoscopic versus Microscopic Surgery in 5-ALA-Guided Resection of High-Grade Gliomas.Journal of clinical medicine · 2024Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFive-aminolevulinic acid (5-ALA) is used for fluorescence-guided resections of malignant glioma at a dose of 20 mg/kg; yet, it is unknown whether lower doses may also provide efficacy.
objectiveTo perform a double-blinded randomized study comparing 3 different doses of 5-ALA.
methodsTwenty-one patients with suspected malignant glioma were randomly assigned to 0.2, 2, or 20 mg/kg 5-ALA. Investigators were unaware of dose. Intraoperatively, regions of interest were first defined in tumor core, margin, and adjacent white matter under white light. Under violet-blue illumination, the surgeon's impression of fluorescence was recorded per region, followed by spectrometry and biopsy. Plasma was collected after administration and analyzed for 5-ALA and protoporphyrin IX (PPIX) content.
resultsThe positive predictive value of fluorescence was 100%. Visual and spectrometric fluorescence assessment showed 20 mg/kg to elicit the strongest fluorescence in tumor core and margins, which correlated with cell density. Spectrometric and visual fluorescence correlated significantly. A 10-fold increase in 5-ALA dose (2-20 mg/kg) resulted in a 4-fold increase of fluorescence contrast between marginal tumor and adjacent brain. t max for 5-ALA was 0.94 h for 20 mg/kg (0.2 kg: 0.50 h, 2 mg/kg: 0.61 h). Integrated PPIX plasma levels were 255.8 and 779.9 mcg*h/l (2 vs 20 mg/kg). Peak plasma concentrations were observed at 1.89 ± 0.71 and 7.83 ± 0.68 h (2 vs 20 mg/kg; average ± Standard Error of Mean [SEM]).
conclusionThe highest visible and measurable fluorescence was yielded by 20 mg/kg. No fluorescence was elicited at 0.2 mg/kg. Increasing 5-ALA doses did not result in proportional increases in tissue fluorescence or PPIX accumulation in plasma, indicating that doses higher than 20 mg/kg will not elicit useful increases in fluorescence.
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