Anaplastic Astrocytoma (AA)Phase 1NCT06665724
Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401)
A Phase 1 study testing 5-Aminolevulinic acid Hydrochloride (Gliolan®) and CV01 in people with Anaplastic Astrocytoma (AA) and Anaplastic Oligodendroglioma (AO), run by Universität Münster at 1 site in Germany.
Trial summary
This trial is designed to evaluate safety and explore possible efficacy of 5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®) with CV01 delivery of ultrasound for sonodynamic therapy in patients with newly diagnosed high-grade glioma prior to resection and standard adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Glioblastoma (GBM)
- What is being tested?
- 5-Aminolevulinic acid Hydrochloride (Gliolan®) and CV01
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2025to 9 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- WHO Performance Status of 0-2
- Patients with cranial MRI displaying typical features of high-grade glioma on imaging or histologically proven high-grade glioma including GBM, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO). No previous tumor specific treatment such as surgery (apart from biopsy), radio- or chemotherapy, antiangiogenic or immunotherapy.
- Planned debulking or cytoreductive surgery
- The following laboratory values at study entry
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
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- Platelet count ≥ 100,000 cells/mm3
- Hemoglobin (Hgb) > 10g/dL
- AST and ALT ≤ 2.5 x Upper Limit of Normal (ULN)
- Total bilirubin ≤ 1.5 x ULN
- Creatine clearance (CrCL) as estimated by Cockcroft-Gault equation of
- ≥ 40 mL/min
- Blood clotting within acceptable limits according to investigator
- For female and male patients and their female partners of childbearing/reproductive potential: Willingness to apply highly effective contraception (Pearl index <1) during the entire study and in female patients for 6 months after the last application of Gliolan® and in male patients and their female partners for 3 months after the last application of Gliolan®.
- Ability to understand and provide informed consent
Who cannot join
- Infra-tentorial tumors
- Patients who have clinically significant edema or tumor mass effect requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids)
- Women who are pregnant or breastfeeding
- Inability to undergo MRI or receive gadolinium (Gd)
- Hypersensitivity to 5-ALA or porphyrins
- Average skull thickness at the treatment field > 10 mm from standard navigation CTs. The treatment field is defined as the various locations on the head where the transducer will be coupled to the patient. The average skull thickness at each treatment field will be determined through post-processing the thin cut head computed tomography (CT) scan (without contrast).
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- Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma biopsy. History of prior intratumoral bleeding is not an exclusion criterion; however, all patient's navigation CTs will be reviewed for the presence of fresh blood.
- Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial
- Known acute or chronic types of porphyria
- Gastrointestinal disorder that negatively affects absorption
- Known active hepatitis B or C (Note: testing is not required)
- Known Human Immunodeficiency Virus (HIV) infection (Note: testing is not required)
- Unable to avoid photosensitising drugs (eg, St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines) for up to 2 weeks following 5-ALA administration
- Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g, clinically significant pulmonary disease, clinically significant psychiatric or neurological disorder, active or uncontrolled infection)
- Diagnosis of other invasive cancer (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last 5 years; adequately treated carcinoma in situ is allowed
- Patient has a condition the investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
- Patients who are dependent on the sponsor, investigator or trial site
- Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery, University Hospital Münster
Münster, 48149
About this study
Official title: A Phase 1 Single Center Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy
This trial is designed to evaluate safety and explore possible efficacy of 5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®) with CV01 delivery of ultrasound for sonodynamic therapy in patients with newly diagnosed high-grade glioma prior to resection and standard adjuvant therapy.
The study will accrue 10 evaluable high-grade glioma patients. Patients who qualify will receive sonodynamic therapy (5 ALA combined with CV01-delivered sonication) 2 to 5 days prior to standard resection, with one study magnetic resonance imaging being performed between sonodynamic therapy and resection. Resection will be followed by standard radio-/chemotherapy. All patients will be followed up in-study for toxicities and adverse events for 28 days.
- Being tested
- 5-Aminolevulinic acid Hydrochloride (Gliolan®), CV01
- Keywords
- newly diagnosed high-grade glioma, sonodynamic therapy
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Aminolevulinic acid Hydrochloride (Gliolan®)Drug
Patients will receive 5-Aminolevulinic acid hydrochloride via oral administration (20 mg/kg) 6-8 hours before CV01 treatment.
CV01Device
Ultrasound will be delivered 6-8 hours after administration of 5-aminolevulinic acid hydrochloride. A total of 12 fields will be treated (10 treatment sites across the hemisphere with 2 additional treatments over areas of increased enhancement).
| Study group | Role | What they receive |
|---|---|---|
| Sonodynamic Therapy (SDT) | Experimental | Patients will receive sonodynamic therapy (5 ALA combined with CV01-delivered sonication) 2 to 5 days prior to standard resection. Receives: Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®); Device: CV01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Clinical safety and tolerability will be assessed based on the observation of adverse events (AEs). Adverse events will be graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.
Measured: From the time the informed consent is signed until 28 days following administration of sonodynamic therapy (end of trial participation)
Secondary outcomes (2)
Radiological changes
Radiological changes (MRI) of Tumor volume, Volume of FLAIR hyperintensity, Volume of cyctotoxic edema, Relative cerebral blood volume and Leakage
Measured: Changes from visit 1 (< 8 days before sonodynamic therapy) to visit 3 (2 to 5 days after sonodynamic therapy)
Histopathological efficacy
Anti-tumor activity assessed by Number of cells / mm³ with antibodies against IBA1 and Number of cells / mm³ with antibodies against Caspase III
Measured: Biopsies will be collected during standard surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start27 Jan 2025
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Astrocytoma (AA)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Collaborators
- Alpheus Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Walter Stummer, Univ.-Prof. Dr. med., Principal investigator, Department of Neurosurgery, University Hospital Münster, Münster, Germany, 48149
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665724
- Sponsor's protocol ID
- WWU22_0032
- Other IDs
- 2023-509238-20-00, UTN: U1111-1296-1261, 2023
- Status last verified
- Feb 2026
- First submitted
- 29 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Center Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy
- ClinicalTrials.gov ID
- NCT06665724
- Acronym / sponsor ID
- WWU22_0032
- Keywords
- newly diagnosed high-grade glioma, sonodynamic therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Collaborators
- Alpheus Medical, Inc.
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 30 Oct 2024 (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 trial is designed to evaluate safety and explore possible efficacy of 5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®) with CV01 delivery of ultrasound for sonodynamic therapy in patients with newly diagnosed high-grade glioma prior to resection and standard adjuvant therapy.
The study will accrue 10 evaluable high-grade glioma patients. Patients who qualify will receive sonodynamic therapy (5 ALA combined with CV01-delivered sonication) 2 to 5 days prior to standard resection, with one study magnetic resonance imaging being performed between sonodynamic therapy and resection. Resection will be followed by standard radio-/chemotherapy. All patients will be followed up in-study for toxicities and adverse events for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonodynamic Therapy (SDT) | Experimental | Drug: 5-Aminolevulinic acid Hydrochloride (Gliolan®), Device: CV01Patients will receive sonodynamic therapy (5 ALA combined with CV01-delivered sonication) 2 to 5 days prior to standard resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- WHO Performance Status of 0-2
- Patients with cranial MRI displaying typical features of high-grade glioma on imaging or histologically proven high-grade glioma including GBM, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO). No previous tumor specific treatment such as surgery (apart from biopsy), radio- or chemotherapy, antiangiogenic or immunotherapy.
- Planned debulking or cytoreductive surgery
- The following laboratory values at study entry
Key exclusion criteria (18 listed)
- Infra-tentorial tumors
- Patients who have clinically significant edema or tumor mass effect requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids)
- Women who are pregnant or breastfeeding
- Inability to undergo MRI or receive gadolinium (Gd)
- Hypersensitivity to 5-ALA or porphyrins
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 (Gliolan®)Patients will receive 5-Aminolevulinic acid hydrochloride via oral administration (20 mg/kg) 6-8 hours before CV01 treatment. | Drug | Sonodynamic Therapy (SDT) |
| CV01Ultrasound will be delivered 6-8 hours after administration of 5-aminolevulinic acid hydrochloride. A total of 12 fields will be treated (10 treatment sites across the hemisphere with 2 additional treatments over areas of increased enhancement). | Device | Sonodynamic Therapy (SDT) |
Primary outcome
Safety and tolerability
Time frame: From the time the informed consent is signed until 28 days following administration of sonodynamic therapy (end of trial participation)
Clinical safety and tolerability will be assessed based on the observation of adverse events (AEs). Adverse events will be graded as per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.
2 secondary outcomes
Radiological changes
Time frame: Changes from visit 1 (< 8 days before sonodynamic therapy) to visit 3 (2 to 5 days after sonodynamic therapy)
Histopathological efficacy
Time frame: Biopsies will be collected during standard surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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. This study is not recruiting at the moment.
Walter Stummer, Univ.-Prof. Dr. med. principal investigator
Department of Neurosurgery, University Hospital Münster, Münster, Germany, 48149
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5-Aminolevulinic acid Hydrochloride (Gliolan®) and CV01 in people with Anaplastic Astrocytoma (AA) and Anaplastic Oligodendroglioma (AO), run by Universität Münster at 1 site in Germany.
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 15 inclusion and 18 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: From the time the informed consent is signed until 28 days following administration of sonodynamic therapy (end of trial participation)). 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 Feb 2026.