A Phase 3 interventional study of 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution in 5-aminolevulinic Acid, Fluorescence-guided Resection and High-Grade Glioma (WHO III-IV), sponsored by Lee's Pharmaceutical Limited. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Lee's Pharmaceutical Limited · Phase 3, Interventional, and Diagnostic
This phase III, multicenter, open-label, single-arm study will evaluate the ability of 5-aminolevulinic acid hydrochloride (5-ALA HCl) powder for oral solution to visualize malignant tissue during surgery, and its safety, in adults with suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4). Participants will receive oral 5-ALA HCl before surgery. The primary assessments will determine the proportion of biopsy specimens containing tumor cells in strongly and weakly fluorescent regions, evaluated separately using central histopathology. Secondary assessments will include postoperative residual tumor on MRI, participant-level positive predictive values, histopathological findings in nonfluorescent regions, and safety.
A multicenter, open-label, single-arm study evaluating intraoperative visualization of malignant tissue and safety in adults with suspected or confirmed malignant high-grade glioma (WHO grade 3 or 4) who are suitable for surgical resection.
After screening, eligible participants will receive 5-ALA HCl powder for oral solution 3 hours before anesthesia (permitted range, 2 to 4 hours). The protocol specifies a dose of 20 mg/kg, with the administered volume selected from its body-weight-based dosing table and a maximum of one 1.5-g vial. One vial will be reconstituted in 50 mL of drinking water. A single 5-mg intravenous infusion of dexamethasone will be administered before oral 5-ALA HCl on the day of surgery.
During surgery, blue-light excitation will be used to identify strongly and weakly fluorescent regions, with switching between blue and white light as needed. Up to seven representative fluorescent tissue specimens per participant will be submitted for histopathological assessment: up to three from strongly fluorescent regions and up to four from weakly fluorescent regions. Where safe and without compromising neurological function, up to two specimens each will also be obtained from nonfluorescent regions adjacent to fluorescence and from nonfluorescent regions distant from the tumor. Independent central pathologists will assess the specimens under blinded conditions.
The primary outcomes are tissue-level positive predictive values for strongly and weakly fluorescent specimens, evaluated separately. Secondary efficacy outcomes include the proportion of participants without residual contrast-enhancing tumor on MRI 24 to 72 hours after surgery, participant-level positive predictive values for each fluorescence intensity, and histopathological positivity rates and negative predictive values in the two nonfluorescent regions. For the MRI outcome, a residual contrast-enhancing lesion volume of 1 cm3 or less is defined as no residual tumor.
Participants will receive light protection for 48 hours after study-drug administration. Safety assessments include adverse events, physical examinations, vital signs, laboratory tests, electrocardiograms, and KPS and NIH-SS assessments as scheduled in the protocol. Procedure-related adverse events will be collected from informed consent until dosing; all adverse events will be collected from dosing through the end of safety follow-up. Adverse events will be graded using NCI CTCAE version 6.0.
1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.
This study's planned enrollment of 79 is above the median of 32 across 1,075 interventional studies indexed under Glioma.
Browse Glioma studies →Lee's Pharmaceutical Limited is the lead sponsor of 74 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 27, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory results meeting all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral 5-ALA HCl 3 hours before anesthesia (range, 2 to 4 hours), followed by surgery with fluorescence visualization of malignant glioma. The protocol specifies 20 mg/kg, with the administered volume selected from the protocol dosing table and a maximum dose of 1.5 g. A single 5-mg intravenous infusion of dexamethasone will be given before oral 5-ALA HCl on the day of surgery. Tissue specimens will be collected for blinded central histopathological assessment. Contrast-enhanced cranial MRI will be performed 24 to 72 hours after surgery.
Drug: 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution
One 1.5-g vial will be reconstituted in 50 mL of drinking water to give a 30-mg/mL solution. The protocol specifies 20 mg/kg; the administered volume will be selected from the protocol body-weight-based dosing table, up to a maximum of one vial (1.5 g). The solution will be administered orally 3 hours before anesthesia (range, 2 to 4 hours) on the day of surgery.
Also known as: 5-ALA HCl
Positive Predictive Value
The percentage of biopsy specimens from strongly and weakly fluorescent regions that are positive for tumor cells on blinded central histopathological assessment. Positive predictive value will be calculated separately for strong and weak fluorescence as the number of tumor-positive biopsy specimens divided by the total number of biopsy specimens of the same fluorescence intensity, multiplied by 100. The unit of analysis is the tissue specimen. Strong and weak fluorescence correspond to red and pink fluorescence, respectively, observed under blue-light excitation.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Percentage of Participants Without Residual Contrast-Enhancing Tumor on Postoperative MRI
The percentage of participants without residual tumor on contrast-enhanced cranial MRI performed 24 to 72 hours after surgery, compared with preoperative MRI. No residual tumor is defined in the protocol as a residual contrast-enhancing lesion volume of 1 cm3 or less.
Time frame: 24 to 72 hours after surgery
Participant-Level Positive Predictive Value for Fluorescence
The percentage of participants in whom all biopsy specimens of a given fluorescence intensity (strong or weak) are positive for tumor cells on blinded central histopathological assessment.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Histopathological Positivity Rate in Nonfluorescent Tissue Adjacent to Fluorescent Regions
The percentage of biopsy specimens from nonfluorescent tissue adjacent to fluorescent regions that are positive for tumor cells on central histopathological assessment. The unit of analysis is the tissue specimen. Specimens will be collected only where safe and without compromising neurological function.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Negative Predictive Value of Nonfluorescent Tissue Adjacent to Fluorescent Regions
The percentage of biopsy specimens from nonfluorescent tissue adjacent to fluorescent regions that are negative for tumor cells on central histopathological assessment. The unit of analysis is the tissue specimen. Specimens will be collected only where safe and without compromising neurological function.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Histopathological Positivity Rate in Nonfluorescent Tissue Distant From the Tumor
The percentage of biopsy specimens from nonfluorescent tissue distant from the tumor that are positive for tumor cells on central histopathological assessment. The unit of analysis is the tissue specimen. Specimens will be collected only where safe and without compromising neurological function.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Negative Predictive Value of Nonfluorescent Tissue Distant From the Tumor
The percentage of biopsy specimens from nonfluorescent tissue distant from the tumor that are negative for tumor cells on central histopathological assessment. The unit of analysis is the tissue specimen. Specimens will be collected only where safe and without compromising neurological function.
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Incidence of Adverse Events
The number and percentage of participants with adverse events will be summarized, with separate summaries for treatment-emergent adverse events, serious adverse events, adverse drug reactions, and postoperative complications. Events will be coded using MedDRA and graded using NCI CTCAE version 6.0. Procedure-related events will be collected from informed consent until study-drug administration; all adverse events will be collected from dosing through the end of safety follow-up. The final time window will follow the protocol-defined safety visit schedule.
Time frame: From informed consent through the final safety follow-up visit (Day 14, with a +14-day window)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2027, 32 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Feb 2026 → Dec 2027 and completion Mar 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Aminolevulinic Acid
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