Pediatric Brain TumorPhase 2NCT06907485
A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients
A Phase 2 study testing Aminolevulinic acid hydrochloride in people with Pediatric Brain Tumor, run by Costas Hadjipanayis at 2 sites in United States.
Trial summary
This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pediatric Brain Tumor
- What is being tested?
- Aminolevulinic acid hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2027to Aug 2029
- Phase
- Phase 2
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects included in this trial must have had an MRI documentation of "a new or recurrent primary pediatric brain tumor" for which resection is indicated and has been planned.
- The anticipated histology at resection will be "newly diagnosed" or "recurrent": pilocytic astrocytoma, pleomorphic xanthoastrocytoma (PXA), ganglioglioma, diffuse neuroepithelial tumor (DNET), astrocytoma, oligodendroglioma, ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic ganglioglioma, anaplastic PXA, PNET, ATRT, or medulloblastoma.
- Male or Female Age 2-17 years and 182 days
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes >3,000/mL Platelets >100,000/mL Total bilirubin Below upper limit of normal (ULN) AST (SGOT)/ALT (SGPT)/ GGT <2.5 X institutional age-specific ULN Creatinine Below ULN
- OR
Show all 10Show fewer
- Creatinine Clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional age-specific normal as defined per institution.
- The effects of 5-ALA on the developing human fetus are unknown. A pregnancy test will be performed for all young women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a young woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability for patient/patient's guardian to understand and the willingness to sign a written informed consent document. In appropriate cases, assent of pediatric patients will be obtained. Translation will be provided as appropriate.
- Inclusion of Women and Minorities: Both males and females and members of all ethnic groups are eligible for this trial.
Who cannot join
- Patients who meet inclusion criteria but are unable to swallow 5-ALA solution.
- Patients with radiographic tumors of the brain stem as assessed by MRI.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA. Patients should refrain from use of other potential phototoxic substances (e.g., tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 24 h.
- Personal or family history of porphyria.
- Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, heart disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated 5-ALA.
- Young women who are pregnant or become pregnant will be excluded from the trial as it is unknown if 5-ALA is teratogenic or has abortifacient effects. A pregnancy test will be performed on all young women who are s/p menstruation prior to entering study.
- Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge
Chicago, Illinois, 60068
John Ruge, MD, 847-723-6611, john.ruge@aah.org
John Ruge, MD
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Swetha Thambireddy, MPH, 412-692-9960, swetha.thanbireddy@chp.edu
Cody Nesvick, MD
About this study
Official title: A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.
For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.
Read the detailed description
The aim of this study is to assess the feasibility of administering 5-ALA pre-operatively and to access if the resulting 5-ALA-induced tumor fluorescence is adequate for fluorescence-guided brain tumor resection in pediatric patients.
In this single-arm, multicenter study, the guardians of the pediatric patient with a newly diagnosed or select recurrent brain tumors will provide consent for the administration of 5-ALA. In relevant cases, assent from the pediatric patients will also be obtained. A total of twenty pediatric brain tumor patients will be treated to evaluate the feasibility of using 5-ALA in this population. All enrolled patients will receive an oral solution of 5-ALA at a dose of 20mg/kg body weight 6-12 hours prior to surgery, followed by tumor resection using either the institutional standard of care or the surgeon's preferred technique.
Resection of fluorescent and non-fluorescent areas will proceed at the surgeon's discretion and the surgeon will indicate the fluorescence of each section. The fluorescence will be characterized as 'none', 'weak,' 'moderate,' or 'strong'; and described as 'patchy' or 'uniform'. When positive fluorescence is present, fluorescence-guided surgery will be performed under white light visualization with the ability to select for the use of appropriate filters adapted to the surgical microscope to allow specific wavelength of blue light to excite the tumor tissue during the operative procedure. Tissue fluorescence will be recorded by intraoperative photography. Biopsies, routinely performed during surgical tumor resection, will be obtained. An additional three to six research tissue specimens will be collected per patient for histopathologic analysis. If fluorescence is present in the tumor, three fluorescent specimens will be obtained from the tumor-core, tumor-margin, and regions just distant to the tumor margins as well as three non-fluorescent tissue specimens will be obtained adjacent to the resection cavity. If no fluorescence is visualized, this will be documented, and only three samples of non-fluorescent tissue specimens will be obtained from the tumor-core, tumor-margin, and regions just distant to the tumor margins.
Histopathologic analysis on all collected fluorescent and non-fluorescent tissue specimens will be performed by a neuropathologist who will not be informed of the fluorescence status of the tissue specimens. The neuropathologist will characterize the biopsies and the additional three to six research tissue specimens by WHO grade, tumor type, and the number of tumor cells present. If institutions perform routine genetic and molecular analysis on resected tissue, this data will also be collected.
5-ALA makes a person more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. Skin photosensitization lasts from approximately 24 to 48 hours following 5-ALA administration. It is for this reason that patients will be kept in low light conditions for 48 hours following surgery.
Patients will undergo standard of care clinical assessments, including physical exams, neurological assessments (Karnofsky Performance Scale and the Lansky Scale), and laboratory evaluations, at several time points: upon entry into the trial (before surgery), within 48 hours after surgery, 2-weeks post-surgery, 6-weeks post-surgery, 3-months post-surgery, and 6-months post-surgery. MRIs will be conducted as part of standard care before surgery, within 48 hours of surgery, and at 3-months post-surgery, and 6-months post-surgery. All patients enrolled on the study will be monitored according to the protocol for 6-months post-surgery.
- Conditions
- Pediatric Brain Tumor
- Being tested
- Aminolevulinic acid hydrochloride
- Keywords
- Aminolevulinic Acid (ALA), Gleolan®, Fluorescence-Guided Resection, Brain Tumor, Pediatric
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic acid hydrochlorideDrug
Also called Gleolan®, ALA HCl, 5-ALA, Aminolevulinic acid HCl
Pediatric patients diagnosed with a new or recurrent brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal will receive aminolevulinic acid hydrochloride prior to surgery for resection of the brain tumor.
| Study group | Role | What they receive |
|---|---|---|
| Aminolevulinic acid hydrochloride | Experimental | Single arm study administering a single oral solution of aminolevulinic acid hydrochloride at a dose of 20 mg/kg body weight, 6-12 hours prior to brain surgery for resection of the tumor. Receives: Drug: Aminolevulinic acid hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall frequency/rate of positive fluorescence in all patients that receive 5-ALA
Overall frequency/rate of positive fluorescence, which is defined as patients with at least one tissue sample with positive fluorescence (score of at least weak and patchy) after using 5-ALA, in all patients administrated 5-ALA with a suspected primary or recurrent brain tumor that is considered to be a low grade (WHO grade I/II) or high grade (WHO grade III/IV) glioma.
Measured: Day of Surgery
Secondary outcomes (6)
Frequency/rate of positive fluorescence within each tumor type
Presence or absence of fluorescence in each tumor type.
Measured: Day of Surgery
Fluorescence quality in all patients receiving 5-ALA and within each tumor type
Fluorescence will be categorized as 'none,' 'weak,' 'moderate,' or 'strong,' and described as 'patchy' or 'uniform.' If fluorescence is present, surgery will be guided by white light with appropriate filters to excite the tumor tissue. Intraoperative photos will capture tissue fluorescence. Biopsies will be taken, including 3-6 additional research specimens per patient for histopathologic analysis. If fluorescence is present, three fluorescent samples will be collected from the tumor core, margin, and areas near the margin, along with three non-fluorescent samples from the resection cavity. If no fluorescence is seen, only non-fluorescent samples from the tumor core, margin, and surrounding areas will be collected. All samples will undergo histopathological examination by a neuropathologist for WHO grade, tumor type, and cell count. Genetic and molecular analysis data will be collected if available.
Measured: Day of Surgery
Accrual rate for each tumor type
Histopathology assessment will characterize the standard of care biopsies by WHO grade and tumor type. If institutions perform routine genetic and molecular analysis of resected tissue, this data will also be collected.
Measured: Day of Surgery
Determination of the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of tumor fluorescence.
Sensitivity of 5-ALA induced fluorescence is calculated as proportion of all tumor (confirmed by histopathology analysis) specimens with positive fluorescence. Specificity is the proportion of all tumor (confirmed by histopathology analysis) specimens without the presence of fluorescence. Positive predictive value (PPV) is defined as proportion of tissues with 5-ALA induced fluorescence that were confirmed tumor on histopathology. Negative predictive value (NPV) is the proportion of tissues without fluorescence that were confirmed tumor by histopathology. In addition PPV will also be calculated with the proportion of tissues with no visible 5-ALA-induced fluorescence but with detectable levels of fluorescence through novel detection system that were confirmed malignant on pathology.
Measured: Day of Surgery
Frequency/rate of AE in all patients receiving ALA and for each tumor type
All adverse events will be collected from the time of drug administration until 6 months following surgery. In addition, serious adverse events (SAE) will be collected beginning from the time the consent/ assent is obtained. The descriptions and grading scales found in the revised NCI CTCAE version 5.0, which will be utilized for adverse event reporting are available online at http://ctep.cancer.gov/reporting/ctc.html.
Measured: Day of Consent signing, day of surgery; within 48 hours of surgery; 2-weeks post-surgery, 6-weeks post-surgery, 3-months post-surgery, 6-months post-surgery
6-month progression free survival (PFS)
Standard of care, gadolinium-enhanced brain MRI will be obtained at 3- and 6-months after tumor resection to assess surgical field and progression.
Measured: 6-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startAug 2027 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Costas Hadjipanayis
- Sponsor type
- University, hospital or other
- Collaborators
- NX Development Corp, Southeastern Brain Tumor Foundation, StacheStrong Foundation, Neuroscience Research Foundation, University of Pittsburgh Medical Center, Advocate Hospital System
- Responsible party
- Sponsor-investigator, Costas Hadjipanayis, University of Pittsburgh
- Investigators
- Constantinos G. Hadjipanayis, MD, PhD, Study director, University of PittsburghJohn Ruge, MD, FAANS, Principal investigator, Midwest Children's Brain Tumor Center, Advocate Children's Hospital-Park Ridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907485
- Sponsor's protocol ID
- STUDY22120058
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration
- ClinicalTrials.gov ID
- NCT06907485
- Acronym / sponsor ID
- STUDY22120058
- Conditions
- Pediatric Brain Tumor
- Keywords
- Aminolevulinic Acid (ALA), Gleolan®, Fluorescence-Guided Resection, Brain Tumor, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Costas HadjipanayisUniversity, hospital or other
- Collaborators
- NX Development Corp, Southeastern Brain Tumor Foundation, StacheStrong Foundation, Neuroscience Research Foundation, University of Pittsburgh Medical Center, Advocate Hospital System
- Study start
- Aug 2027 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 2 Apr 2025 (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 clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.
For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.
Detailed description
The aim of this study is to assess the feasibility of administering 5-ALA pre-operatively and to access if the resulting 5-ALA-induced tumor fluorescence is adequate for fluorescence-guided brain tumor resection in pediatric patients.
In this single-arm, multicenter study, the guardians of the pediatric patient with a newly diagnosed or select recurrent brain tumors will provide consent for the administration of 5-ALA. In relevant cases, assent from the pediatric patients will also be obtained. A total of twenty pediatric brain tumor patients will be treated to evaluate the feasibility of using 5-ALA in this population. All enrolled patients will receive an oral solution of 5-ALA at a dose of 20mg/kg body weight 6-12 hours prior to surgery, followed by tumor resection using either the institutional standard of care or the surgeon's preferred technique.
Resection of fluorescent and non-fluorescent areas will proceed at the surgeon's discretion and the surgeon will indicate the fluorescence of each section. The fluorescence will be characterized as 'none', 'weak,' 'moderate,' or 'strong'; and described as 'patchy' or 'uniform'. When positive fluorescence is present, fluorescence-guided surgery will be performed under white light visualization with the ability to select for the use of appropriate filters adapted to the surgical microscope to allow specific wavelength of blue light to excite the tumor tissue during the operative procedure. Tissue fluorescence will be recorded by intraoperative photography. Biopsies, routinely performed during surgical tumor resection, will be obtained. An additional three to six research tissue specimens will be collected per patient for histopathologic analysis. If fluorescence is present in the tumor, three fluorescent specimens will be obtained from the tumor-core, tumor-margin, and regions just distant to the tumor margins as well as three non-fluorescent tissue specimens will be obtained adjacent to the resection cavity. If no fluorescence is visualized, this will be documented, and only three samples of non-fluorescent tissue specimens will be obtained from the tumor-core, tumor-margin, and regions just distant to the tumor margins.
Histopathologic analysis on all collected fluorescent and non-fluorescent tissue specimens will be performed by a neuropathologist who will not be informed of the fluorescence status of the tissue specimens. The neuropathologist will characterize the biopsies and the additional three to six research tissue specimens by WHO grade, tumor type, and the number of tumor cells present. If institutions perform routine genetic and molecular analysis on resected tissue, this data will also be collected.
5-ALA makes a person more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. Skin photosensitization lasts from approximately 24 to 48 hours following 5-ALA administration. It is for this reason that patients will be kept in low light conditions for 48 hours following surgery.
Patients will undergo standard of care clinical assessments, including physical exams, neurological assessments (Karnofsky Performance Scale and the Lansky Scale), and laboratory evaluations, at several time points: upon entry into the trial (before surgery), within 48 hours after surgery, 2-weeks post-surgery, 6-weeks post-surgery, 3-months post-surgery, and 6-months post-surgery. MRIs will be conducted as part of standard care before surgery, within 48 hours of surgery, and at 3-months post-surgery, and 6-months post-surgery. All patients enrolled on the study will be monitored according to the protocol for 6-months post-surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aminolevulinic acid hydrochloride | Experimental | Drug: Aminolevulinic acid hydrochlorideSingle arm study administering a single oral solution of aminolevulinic acid hydrochloride at a dose of 20 mg/kg body weight, 6-12 hours prior to brain surgery for resection of the tumor. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Subjects included in this trial must have had an MRI documentation of "a new or recurrent primary pediatric brain tumor" for which resection is indicated and has been planned.
- The anticipated histology at resection will be "newly diagnosed" or "recurrent": pilocytic astrocytoma, pleomorphic xanthoastrocytoma (PXA), ganglioglioma, diffuse neuroepithelial tumor (DNET), astrocytoma, oligodendroglioma, ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic ganglioglioma, anaplastic PXA, PNET, ATRT, or medulloblastoma.
- Male or Female Age 2-17 years and 182 days
- Subjects must have normal organ and marrow function as defined below:
- Leukocytes >3,000/mL Platelets >100,000/mL Total bilirubin Below upper limit of normal (ULN) AST (SGOT)/ALT (SGPT)/ GGT <2.5 X institutional age-specific ULN Creatinine Below ULN
Key exclusion criteria (7 listed)
- Patients who meet inclusion criteria but are unable to swallow 5-ALA solution.
- Patients with radiographic tumors of the brain stem as assessed by MRI.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA. Patients should refrain from use of other potential phototoxic substances (e.g., tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 24 h.
- Personal or family history of porphyria.
- Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, heart disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated 5-ALA.
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 |
|---|---|---|
| Aminolevulinic acid hydrochlorideAlso: Gleolan®, ALA HCl, 5-ALA, Aminolevulinic acid HClPediatric patients diagnosed with a new or recurrent brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal will receive aminolevulinic acid hydrochloride prior to surgery for resection of the brain tumor. | Drug | Aminolevulinic acid hydrochloride |
Primary outcome
Overall frequency/rate of positive fluorescence in all patients that receive 5-ALA
Time frame: Day of Surgery
Overall frequency/rate of positive fluorescence, which is defined as patients with at least one tissue sample with positive fluorescence (score of at least weak and patchy) after using 5-ALA, in all patients administrated 5-ALA with a suspected primary or recurrent brain tumor that is considered to be a low grade (WHO grade I/II) or high grade (WHO grade III/IV) glioma.
6 secondary outcomes
Frequency/rate of positive fluorescence within each tumor type
Time frame: Day of Surgery
Fluorescence quality in all patients receiving 5-ALA and within each tumor type
Time frame: Day of Surgery
Accrual rate for each tumor type
Time frame: Day of Surgery
Determination of the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of tumor fluorescence.
Time frame: Day of Surgery
Frequency/rate of AE in all patients receiving ALA and for each tumor type
Time frame: Day of Consent signing, day of surgery; within 48 hours of surgery; 2-weeks post-surgery, 6-weeks post-surgery, 3-months post-surgery, 6-months post-surgery
6-month progression free survival (PFS)
Time frame: 6-months post-surgery
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 7 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.
Constantinos G. Hadjipanayis, MD, PhD study director
University of Pittsburgh
John Ruge, MD, FAANS principal investigator
Midwest Children's Brain Tumor Center, Advocate Children's Hospital-Park Ridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolevulinic acid hydrochloride in people with Pediatric Brain Tumor, run by Costas Hadjipanayis at 2 sites in United States.
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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Kristy Boggs, PhD (412-647-8952, boggskd@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall frequency/rate of positive fluorescence in all patients that receive 5-ALA (time frame: Day of Surgery). 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 7 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.