Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT06160492
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 ≤ 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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06160492
Study Brief:
Protocol Section:
NCT06160492