Neoplasms

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Glioma

Neoplasms, Neuroepithelial

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Neuroectodermal Tumors, Primitive

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Neoplasms, Nerve Tissue

Neuroepithelioma

Central Nervous System Depressants

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Anesthetics

Aminolevulinic Acid

Photosensitizing Agents

3±1 hours before anesthesia, participants will take 5-ALA orally at a dosage of 20 mg/kg, followed by fluorescence-guided resection of malignant glioma.

5 Aminolevulinic Acid

jingsong wu, doctor

jingsong wu, Doctor

This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3\~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.

Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid

The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas.

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioblastoma

Brain Neoplasms

5-aminolevulinic acid \[5-ALA\] with CV01-delivered ultrasound

5-aminolevulinic acid \[5-ALA\] administered orally 20 mg/kg every 4 weeks

CV01-delivered ultrasound

A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).

High-grade gliomas are the most commonly occurring primary CNS tumors in adults. The investigational product in this clinical study is a drug-device combination product consisting of 5-ALA HCl oral solution and the CV01 ultrasound delivery device. 5-ALA will be administered as a sonosensitizer prior to CV01-delivered ultrasound and will be re-administered every 4 weeks prior to CV01 ultrasound delivery. The CV01 device will deliver non-ablative, low-intensity ultrasound to deep regions of the brain to induce apoptosis of cancer cells. Part A will focus on duration escalation and determining the recommended duration of CV01 delivered ultrasound. Part B will further explore safety and tolerability through cohort expansion at the recommended duration of CV01 delivered ultrasound. Part C will include an exploratory surgical cohort at the recommended duration of CV01 delivered ultrasound. This FIH study will evaluate escalating durations of ultrasound delivery with CV01 and will enroll up to 48 patients.

Part A will include cohorts at escalating duration of sonication. Parts B and C will include the recommended duration as determined in Part A.

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma

A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG)

Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)

The MTDu is defined as the highest duration at which fewer than 1/3 of patients experience a Duration limited toxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）	NCT06417281	5-aminolevulini... Malignant Gliom...	5 Aminolevulini...	18 Years - 75 Years	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma	NCT05362409	High Grade Glio...	5 Aminolevulini... CV01-delivered ...	18 Years -	Alpheus Medical, Inc.

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