High Grade GliomaEarly Phase 1NCT04559685
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma
A Early Phase 1 study testing SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) and MR-Guided Focused Ultrasound device (MRgFUS) in people with High Grade Glioma, run by Nader Sanai at 1 site in United States.
Trial summary
A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) and MR-Guided Focused Ultrasound device (MRgFUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 10 Nov 2024
- Phase
- Early 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
- Arms A-D: Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard therapy as determined by the investigator. Arm E: Participant at first recurrence with an unmethylated HGG, has completed standard therapy and is not currently scheduled for resection.
- Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion.
- Arms A-D (only): Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and ≤ 20cm3 of targeted treatment area.
- Age ≥18 at time of consent.
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982).
- Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility)
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- Adequate bone marrow function:
- absolute neutrophil count ≥1,000/mcL
- Platelets (at time of surgery) ≥100,000/mcL
- hemoglobin ≥8.0 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
- Adequate hepatic and renal function:
- total bilirubin ≤1.5 X ULN. Participants with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
- AST(SGOT) ≤3 X institutional ULN
- ALT(SGPT) ≤3 X institutional ULN
- GGT ≤3 X institutional ULN
- Serum creatinine ≤1.5 X institutional ULN
- Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of treatment administration.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 1 month after the end of treatment administration. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner to prevent delivery of the drug via seminal fluid.
- Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 14 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy).
- Participants who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and Day 1.
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
- Has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- Willingness and ability to comply with scheduled visits, treatment plans, Lifestyle Considerations, laboratory tests and other procedures.
Who cannot join
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke.
- Significant vascular disease (e.g. aortic aneurysm)
- Evidence of bleeding diathesis or coagulopathy
- Diagnosis of porphyria
- Unstable angina and/or congestive heart failure within the last 6 months
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- Transmural myocardial infarction within the last 6 months
- Serious and inadequately controlled cardiac arrhythmia
- Acute exacerbation of chronic obstructive pulmonary disease
- Inability to undergo MRI (e.g., presence of a pacemaker)
- Pregnancy or breastfeeding
- Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
- Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- Hypersensitivity against porphyrins
- Treatment with another investigational drug within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
- Has an Overall Skull Density Ratio of 0.45 (±0.05) or less as calculated from the screening CT.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: A Phase 0, First in Human, Open-label Study of Intravenous Aminolevulinic Acid HCl (ALA) and MR-Guided Focused Ultrasound Device (MRgFUS) in Participants With Recurrent High Grade Glioma (HGG)
A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).
- Conditions
- High Grade Glioma
- Being tested
- SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS), MR-Guided Focused Ultrasound device (MRgFUS)
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)Combination product
SONALA-001(ALA) given 5-7 hours prior to receiving the MRgFUS.
MR-Guided Focused Ultrasound device (MRgFUS)Device
MR-Guided Focused Ultrasound device (MRgFUS) alone
| Study group | Role | What they receive |
|---|---|---|
| Arm A Energy Dose-escalation | Experimental | In Arm A, the dose-escalation cohort, there will be 3 cohorts of ascending MRgFUS power/energy dose combinations with a fixed SONALA-001 dose and fixed surgical time. Arm A will determine the power/energy dose combination for Arm B. Receives: Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) |
| Arm B Time-escalation | Experimental | In Arm B, the time-escalation cohort, the SONALA-001 and power/energy dose combination will be fixed. Participants will be enrolled into two time cohorts (2 days and 6 days post-SDT). Receives: Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) |
| Arm C ALA Dose-escalation | Experimental | In Arm C, the MRgFUS power/energy dose will be fixed based on Arm A MTD/OBD, with the SONALA-001 dose escalation. Receives: Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) |
| Arm D MRgFUS alone | Experimental | In Arm D, MRgFUS treatment alone will be given at the optimal energy determined from previous Arms. Receives: Device: MR-Guided Focused Ultrasound device (MRgFUS) |
| Arm E Optimal energy and ALA dose | Experimental | In Arm E patients will receive treatment at the optimal energy and ALA dose determined form prior Arms. Receives: Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological changes associated with the sonodynamic therapy
The percentage (%) of Cleaved Caspase-3 of the surgical tissue will be quantified and compared to intra-patient control specimens.
Measured: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
Radiographic evidence of tumor physiological imaging changes associated with SDT in recurrent HGG patients (Arm E)
Volume of enhancing tumor will quantified and compared between pre and post procedural scans (Arm E)
Measured: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
Secondary outcomes (12)
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Dynamic Contrast Enhanced (DCE)-MRI data to quantify permeability
Measured: Pre and 14 Days Post-operative scan
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Dynamic Susceptibility Contrast (DSC)-MRI data to quantify perfusion
Measured: Pre and 14 Days Post-operative scan
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Diffusion Weighted Imaging (DWI) data to evaluate cellularity
Measured: Pre and 14 Days Post-operative scan
To identify oxidative stress in tissue exposed to sonodynamic therapy in recurrent high-grade glioma patients.
To quantify markers for oxidative stress (Protein oxidation (Protein Carbonyl Content), Lipid peroxidation (4-hydroxynonenal and MDA), DNA damage (8-hydroxyguanosine),General (GSH, GSSG, Cys, CySS) in the brain tumor tissue (2-, 4- and 6-days post SDT) (both in SDT and control fractions)
Measured: Intraoperatively 2, 4, or 6 days post sonodynamic therapy
Performance of MRgFUS
Percentage of SDT treatments in which the MRgFUS system works as planned
Measured: Day 1
Performance of MRgFUS
Percentage of treatments in which procedure deviations were noted
Measured: Day 1
Safety and Tolerability
Number and incidence of drug-related toxicity
Measured: up to 30 days after the last study dose
Safety and Tolerability
Adverse device effects
Measured: up to 30 days after the last study dose
To characterize the biological changes associated with sonodynamic therapy in recurrent high-grade glioma patients.
The percentage (%) of MIB-1 level, 4-hydroxynonenal (4-HNE) of the surgical tissue will be quantified and compared to intra-patient control specimens.
Measured: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
Overall Survival
Median overall survival
Measured: 24 months
Progression-free survival
Number of patients who reach 6-month progression- free survival rate (PFS6)
Measured: 6 months
Best Overall Response (BOR)
Proportion of patients with a BOR of CR or PR per RANO
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Mar 2021
- Primary completion23 Aug 2023
- Study completion10 Nov 2024
Why it stopped: Study terminated due to unavailability of the investigational product required to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Grade GliomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, SonALAsense, Inc., InSightec
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559685
- Sponsor's protocol ID
- 2020-11
- Other IDs
- 21-500-032-34-38
- Status last verified
- May 2026
- First submitted
- 11 Sep 2020
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sanai N, Tovmasyan A, Tien AC, Chang YW, Margaryan T, Knight W, Hendrickson K, Eschbacher J, Harmon J, Hong A, Yoo W, Furey C, Marcus SL, Alhilali L, Barani I, Mirzadeh Z, Mehta S. An early clinical trial of 5-ALA sonodynamic therapy in recurrent high-grade glioma. Sci Transl Med. 2025 Nov 26;17(826):eads5813. doi: 10.1126/scitranslmed.ads5813. Epub 2025 Nov 26.
PubMed 41296829
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0, First in Human, Open-label Study of Intravenous Aminolevulinic Acid HCl (ALA) and MR-Guided Focused Ultrasound Device (MRgFUS) in Participants With Recurrent High Grade Glioma (HGG)
- ClinicalTrials.gov ID
- NCT04559685
- Acronym / sponsor ID
- 2020-11
- Conditions
- High Grade Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to unavailability of the investigational product required to continue the study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Barrow Neurological Institute, Ivy Brain Tumor Center, SonALAsense, Inc., InSightec
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 23 Sep 2020 (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.
A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A Energy Dose-escalation | Experimental | Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)In Arm A, the dose-escalation cohort, there will be 3 cohorts of ascending MRgFUS power/energy dose combinations with a fixed SONALA-001 dose and fixed surgical time. Arm A will determine the power/energy dose combination for Arm B. |
| Arm B Time-escalation | Experimental | Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)In Arm B, the time-escalation cohort, the SONALA-001 and power/energy dose combination will be fixed. Participants will be enrolled into two time cohorts (2 days and 6 days post-SDT). |
| Arm C ALA Dose-escalation | Experimental | Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)In Arm C, the MRgFUS power/energy dose will be fixed based on Arm A MTD/OBD, with the SONALA-001 dose escalation. |
| Arm D MRgFUS alone | Experimental | Device: MR-Guided Focused Ultrasound device (MRgFUS)In Arm D, MRgFUS treatment alone will be given at the optimal energy determined from previous Arms. |
| Arm E Optimal energy and ALA dose | Experimental | Combination Product: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)In Arm E patients will receive treatment at the optimal energy and ALA dose determined form prior Arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Arms A-D: Prior resection of histologically diagnosed high-grade gliomas (III and IV) defined as participants who have progressed on or following standard therapy as determined by the investigator. Arm E: Participant at first recurrence with an unmethylated HGG, has completed standard therapy and is not currently scheduled for resection.
- Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion.
- Arms A-D (only): Have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with a volume of at least 6 cm3 and ≤ 20cm3 of targeted treatment area.
- Age ≥18 at time of consent.
- Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982).
Key exclusion criteria (16 listed)
- Known active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
- Have had a recent (≤3 months prior to first dose of study drug) transient ischemic attack or stroke.
- Significant vascular disease (e.g. aortic aneurysm)
- Evidence of bleeding diathesis or coagulopathy
- Diagnosis of porphyria
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 |
|---|---|---|
| SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)SONALA-001(ALA) given 5-7 hours prior to receiving the MRgFUS. | Combination product | Arm A Energy Dose-escalation, Arm B Time-escalation, Arm C ALA Dose-escalation, Arm E Optimal energy and ALA dose |
| MR-Guided Focused Ultrasound device (MRgFUS)MR-Guided Focused Ultrasound device (MRgFUS) alone | Device | Arm D MRgFUS alone |
Primary outcome
Biological changes associated with the sonodynamic therapy
Time frame: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
The percentage (%) of Cleaved Caspase-3 of the surgical tissue will be quantified and compared to intra-patient control specimens.
Radiographic evidence of tumor physiological imaging changes associated with SDT in recurrent HGG patients (Arm E)
Time frame: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
Volume of enhancing tumor will quantified and compared between pre and post procedural scans (Arm E)
12 secondary outcomes
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Time frame: Pre and 14 Days Post-operative scan
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Time frame: Pre and 14 Days Post-operative scan
Radiographic evidence of tumor physiological imaging changes associated with sonodynamic therapy
Time frame: Pre and 14 Days Post-operative scan
To identify oxidative stress in tissue exposed to sonodynamic therapy in recurrent high-grade glioma patients.
Time frame: Intraoperatively 2, 4, or 6 days post sonodynamic therapy
Performance of MRgFUS
Time frame: Day 1
Performance of MRgFUS
Time frame: Day 1
Safety and Tolerability
Time frame: up to 30 days after the last study dose
Safety and Tolerability
Time frame: up to 30 days after the last study dose
To characterize the biological changes associated with sonodynamic therapy in recurrent high-grade glioma patients.
Time frame: Intraoperatively 4, 7, or 14 days post sonodynamic therapy
Overall Survival
Time frame: 24 months
Progression-free survival
Time frame: 6 months
Best Overall Response (BOR)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Study terminated due to unavailability of the investigational product required to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 41296829Sanai N, Tovmasyan A, Tien AC, Chang YW, Margaryan T, Knight W, Hendrickson K, Eschbacher J, Harmon J, Hong A, Yoo W, Furey C, Marcus SL, Alhilali L, Barani I, Mirzadeh Z, Mehta S. An early clinical trial of 5-ALA sonodynamic therapy in recurrent high-grade glioma. Sci Transl Med. 2025 Nov 26;17(826):eads5813. doi: 10.1126/scitranslmed.ads5813. Epub 2025 Nov 26.
- 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.
Nader Sanai, MD principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) and MR-Guided Focused Ultrasound device (MRgFUS) in people with High Grade Glioma, run by Nader Sanai at 1 site 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 24 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 May 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Study terminated due to unavailability of the investigational product required to continue the study.). Results are not available in the source record.
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?
Biological changes associated with the sonodynamic therapy (time frame: Intraoperatively 4, 7, or 14 days post sonodynamic therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559685, which also lists 1 linked publication.
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 14 May 2026.