Evaluating a new method for removing brain tumors using fluorescence guidance

Phase III Clinical Trial Evaluating the Efficacy of 5-aminolevulinic Acid (5-ALA HCl) Fluorescence-guided Microsurgery Versus Conventional White Light Microsurgical Resection in Patients With Malignant Gliomas (WHO Grade 3/4)

This study is testing a new way to remove brain tumors using a special dye that makes the tumor glow, to see if it works better than the usual method for patients with aggressive brain tumors.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Lee's Pharmaceutical Limited (Industry-sponsored)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06160492 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, open-label, multicenter study comparing the effectiveness of 5-aminolevulinic acid (5-ALA HCl) fluorescence-guided microsurgery to conventional white light microsurgery in patients with malignant gliomas (WHO grade 3/4). Participants will be randomly assigned to receive either the fluorescence-guided approach or the traditional method, with the test group receiving 5-ALA HCl prior to surgery. The study aims to assess the efficacy of tumor resection and monitor for any adverse events during the process. Follow-up imaging will be conducted within 72 hours post-surgery to evaluate the outcomes.

Who should consider this trial

Good fit: Ideal candidates are males or females aged 18-70 with newly diagnosed malignant gliomas (WHO grade 3/4) and a Karnofsky Performance Status of 60 or higher.

Not a fit: Patients with other types of brain tumors or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective tumor removal and improved outcomes for patients with malignant gliomas.

How similar studies have performed: Previous studies have shown promising results with fluorescence-guided surgery in brain tumor resections, suggesting potential success for this approach.

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;

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Henan Province Tumor Hospital — Zhengzhou, Henan, China (Recruiting)

Conditions 5-aminolevulinic Acid; Fluorescence-guided Resection