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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient's written informed consent.

- Age 18-75 years.

- Radiological suspicion of a malignant glioma.

- Indication for surgical tumour resection.

- Karnofsky Performance Status (KPS) ≥ 70.

Exclusion Criteria:

- Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem.

- Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases； - known hypersensitivity to the test drug ingredients.

- Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06417281
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	5-aminolevulinic Acid, Malignant Glioma of Brain

Arms & Interventions

Arms

Experimental: 5 Aminolevulinic Acid

This is an single arm study.

Interventions

Drug: - 5 Aminolevulinic Acid

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.

Contact a Trial Team

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International Sites

Huashan Hospital, Fudan University, Shanghai, China

Status

Address

Huashan Hospital, Fudan University

Shanghai, ,

Site Contact

jingsong wu, Doctor

[email protected]

+8613701707118

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