5-aminolevulinic AcidPhase 3NCT06160492
5-Aminolevulinic Acid for Photodynamic Diagnosis of Malignant Glioma
A Phase 3 study testing 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution in people with 5-aminolevulinic Acid and Fluorescence-guided Resection, run by Lee's Pharmaceutical Limited at 2 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 5-aminolevulinic Acid, Fluorescence-guided Resection, High-Grade Glioma (WHO III-IV)
- What is being tested?
- 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesChina
- Study dates
- 14 Apr 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 75 years, inclusive.
- 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.
- At least one contrast-enhancing lesion on cranial MRI.
- 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.
- Karnofsky Performance Status (KPS) of at least 60.
- Ability to take oral medication.
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- Laboratory results meeting all of the following criteria:
- 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.
- 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.
- 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.
- 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.
- 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.
- Ability to understand the informed consent form, voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- Known hypersensitivity to aminolevulinic acid, porphyrins, or structural analogues of either.
- Acute or chronic porphyria, photosensitivity, or a history or current diagnosis of photosensitive skin disease.
- 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.
- 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.
- 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.
- Inability to undergo contrast-enhanced MRI, for example because of a pacemaker or contrast-agent allergy.
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- 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.
- 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.
- 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.
- Any other condition that, in the principal investigator's judgment, makes participation inappropriate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhongping Chen, doctor, +8613500002457, chenzhp@sysucc.org.cn
Deipei Li, doctor, 15622139805, guochch@sysucc.org.cn
- Recruiting
Henan Province Tumor Hospital
Zhengzhou, Henan
zhenyan hao, 15521091783, zlyyhezhenyan4411@zzu.edu.cn
About this study
Official title: A Phase III Clinical Study of 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution for Photodynamic Diagnosis of Malignant Glioma (WHO Grade 3 or 4)
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.
Read the detailed description
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.
- Being tested
- 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic Acid Hydrochloride Powder for Oral SolutionDrug
Also called 5-ALA HCl
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.
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA HCl fluorescence visualization | Experimental | 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. Receives: Drug: 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From informed consent through the final safety follow-up visit (Day 14, with a +14-day window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start14 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 5-aminolevulinic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160492
- Sponsor's protocol ID
- ALA HCl-LEES-2022-01
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study of 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution for Photodynamic Diagnosis of Malignant Glioma (WHO Grade 3 or 4)
- ClinicalTrials.gov ID
- NCT06160492
- Acronym / sponsor ID
- ALA HCl-LEES-2022-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-ALA HCl fluorescence visualization | Experimental | Drug: 5-Aminolevulinic Acid Hydrochloride Powder for Oral SolutionParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female participants aged 18 to 75 years, inclusive.
- 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.
- At least one contrast-enhancing lesion on cranial MRI.
- 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.
- Karnofsky Performance Status (KPS) of at least 60.
Key exclusion criteria (10 listed)
- Known hypersensitivity to aminolevulinic acid, porphyrins, or structural analogues of either.
- Acute or chronic porphyria, photosensitivity, or a history or current diagnosis of photosensitive skin disease.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Aminolevulinic Acid Hydrochloride Powder for Oral SolutionAlso: 5-ALA HClOne 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. | Drug | 5-ALA HCl fluorescence visualization |
Primary outcome
Positive Predictive Value
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
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.
7 secondary outcomes
Percentage of Participants Without Residual Contrast-Enhancing Tumor on Postoperative MRI
Time frame: 24 to 72 hours after surgery
Participant-Level Positive Predictive Value for Fluorescence
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Histopathological Positivity Rate in Nonfluorescent Tissue Adjacent to Fluorescent Regions
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Negative Predictive Value of Nonfluorescent Tissue Adjacent to Fluorescent Regions
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Histopathological Positivity Rate in Nonfluorescent Tissue Distant From the Tumor
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Negative Predictive Value of Nonfluorescent Tissue Distant From the Tumor
Time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.
Incidence of Adverse Events
Time frame: From informed consent through the final safety follow-up visit (Day 14, with a +14-day window)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-Aminolevulinic Acid Hydrochloride Powder for Oral Solution in people with 5-aminolevulinic Acid and Fluorescence-guided Resection, run by Lee's Pharmaceutical Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (time frame: During surgery (Day 1); collected specimens will undergo subsequent central histopathological assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.