Evaluating a new method for removing brain tumors using fluorescence guidance

Inclusion Criteria:

1. Male or female participants aged 18 to 75 years, inclusive.
2. Suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4). The principal investigator must consider the participant suitable for glioma resection, with preoperative assessment indicating that complete tumor resection can be achieved without compromising important physiological functions.
3. At least one contrast-enhancing lesion on cranial MRI.
4. Recovery before study-drug administration from prior treatment-related toxicities to grade 1 or less, or to baseline. Alopecia, hyperpigmentation, and chemotherapy-related peripheral neuropathy may be grade 2 or less.
5. Karnofsky Performance Status (KPS) of at least 60.
6. Ability to take oral medication.
7. Laboratory results meeting all of the following criteria:

   1. Hematology: no hematopoietic growth factors, blood transfusions, coagulation-factor transfusions, platelet transfusions, or albumin infusions within 14 days before blood sampling; absolute neutrophil count at least 1.5 x 10\^9/L, platelet count at least 100 x 10\^9/L, and hemoglobin at least 90 g/L.
   2. Coagulation: international normalized ratio (INR) or prothrombin time (PT) no greater than 1.5 times the upper limit of normal (ULN), and activated partial thromboplastin time (APTT) no greater than 1.5 times ULN. Prolongation of INR, PT, or APTT due to anticoagulant treatment may be permitted at the principal investigator's discretion, as excessive bleeding may be controlled by direct pressure.
   3. Liver function: total bilirubin no greater than 1.5 times ULN, or no greater than 3 times ULN in participants with liver metastases from malignant glioma or confirmed Gilbert syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 2.5 times ULN, or no greater than 5 times ULN in participants with liver metastases from malignant glioma; and serum albumin at least 30 g/L.
   4. Renal function: serum creatinine no greater than 1.5 times ULN, or creatinine clearance at least 50 mL/min calculated using the Cockcroft-Gault formula.
8. Female participants who are not surgically sterile or who are of childbearing potential must have a negative serum pregnancy test and must not be breastfeeding. Female participants of childbearing potential and male participants whose spouses are of childbearing potential must agree to use contraception for 3 months after study-drug administration.
9. Ability to understand the informed consent form, voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.

Exclusion Criteria:

1. Known hypersensitivity to aminolevulinic acid, porphyrins, or structural analogues of either.
2. Acute or chronic porphyria, photosensitivity, or a history or current diagnosis of photosensitive skin disease.
3. MRI evidence of a tumor in a critical functional region, such as the basal ganglia, thalamus, cerebellum, or brainstem, where surgery would severely compromise vital functions.
4. An active infection requiring medication within 2 weeks before study-drug administration, or unexplained fever between screening and dosing accompanied by a markedly elevated procalcitonin level. Participants may be enrolled if the principal investigator determines that the fever is caused by malignant glioma.
5. A history of major gastrointestinal surgery that may alter drug absorption or activity, such as total gastrectomy or small-intestinal resection, or gastrointestinal dysfunction within the preceding 6 months, including chronic inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), lactose intolerance, malabsorption syndrome, gastrointestinal bleeding, bleeding gastric ulcer, chronic diarrhea, or major surgery for intestinal obstruction or perforation.
6. Inability to undergo contrast-enhanced MRI, for example because of a pacemaker or contrast-agent allergy.
7. Another malignancy within the previous 5 years, except low-grade malignancies treated with curative intent, such as basal-cell carcinoma of the skin, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
8. Inadequately controlled cardiovascular disease, including: New York Heart Association (NYHA) functional class II or higher; severe or unstable angina; primary cardiomyopathy; myocardial infarction within 6 months before study-drug administration or a history of coronary or peripheral arterial bypass surgery; hypertension or hypotension judged by the principal investigator to prevent tolerance of surgery and the perioperative period; severe arrhythmia requiring medication and judged by the principal investigator to prevent tolerance of surgery and the perioperative period; or a left ventricular ejection fraction below 50% on screening echocardiography.
9. Active hepatitis B or C, unless antiviral treatment has reduced HBV DNA below the assay's lower detection limit or HCV RNA is negative, as applicable; HIV positivity or a known history of acquired immunodeficiency syndrome.
10. Any other condition that, in the principal investigator's judgment, makes participation inappropriate.