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Compares treatment options for 5-aminolevulinic Acid
Official title 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)
ClinicalTrials.gov ID: NCT06160492
What this study is testing
What is 5-aminolevulinic acid?
5-aminolevulinic acid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for 5-aminolevulinic acid.
Also referred to as 5-ALA HCl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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)...
You likely can't join if
- 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);
- people taking other trial medications within 30 days prior to the start of this trial or people 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...
See the full eligibility 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)...
- Non-surgically sterilized or female people of childbearing potential need to have a negative serum pregnancy test result and must be non-lactating females; female people of childbearing potential and male people whose...
- people 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.
- 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);
- people taking other trial medications within 30 days prior to the start of this trial or people 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.