💬In plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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;