Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
144 (estimated)
Sponsor
Lee's Pharmaceutical Limited · Industry
Who this trial is looking for
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This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).
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Eligibility Criteria
Inclusion Criteria:
* Males or females 18-70 years of age, inclusive;
* Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging;
* have a Karnofsky Performance Status (KPS) ≥ 60;
* Ability to take oral medications;
* Laboratory tests meeting the following criteria within…
Inclusion Criteria:
* Males or females 18-70 years of age, inclusive;
* Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging;
* have a Karnofsky Performance Status (KPS) ≥ 60;
* Ability to take oral medications;
* Laboratory tests meeting the following criteria within ≤ 7 days preoperatively:
Alanine aminotransferase (ALT), Mentholatum aminotransferase (AST), Glutamyl transpeptidase (GGT) \< 100 IU/L; Serum total bilirubin (TBIL) \< 51.3 μmol/L (3.0 mg/dl); Serum creatinine (CRE) \< 176.8 μmol/L (2.0 mg/dl);
* Non-surgically sterilized or female subjects of childbearing potential need to have a negative serum pregnancy test result and must be non-lactating females; female subjects of childbearing potential and male subjects whose spouses are of childbearing potential are voluntarily using contraception for a period of 3 months after administration of the test drug;
* Subjects are able to understand the informed consent form, voluntarily participate and sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Exclusion Criteria:
* Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs;
* acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis
* Tumor located in the midline, basal ganglia, cerebellum, or brainstem;
* Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons);
* Subjects taking other trial medications within 30 days prior to the start of this trial or subjects undergoing other clinical trials at the same time;
* Comorbid uncontrolled cardiac conditions such as: a) New York Heart Association (NYHA) class ≥II, b) severe/unstable angina, c) primary cardiomyopathy, d) myocardial infarction or previous coronary/peripheral artery bypass grafting within ≤6 months prior to the procedure, e) difficult-to-control hypertension, f) severe arrhythmia requiring medication or intervention, and g) screening echocardiographic left ventricular ejection fraction \<50%;
* Active hepatitis B or C (unless HBV-DNA titers below the minimum detection limit and HCV-RNA negative on antiviral therapy can be included), HIV-positive or known history of acquired immunodeficiency syndrome;
* Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;
Contacts
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