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Sonodynamic Therapy for Progressive or Recurrent Glioblastoma

This study is testing a new treatment called sonodynamic therapy for people with glioblastoma that has grown or come back. This therapy combines a drug, either SONALA-001 or 5-ALA HCL, with a special type of ultrasound called magnetic resonance-guided focused ultrasound (MRgFUS). The goal is to see if this combination is safe and how well it works to shrink tumors. Researchers will be looking for any side effects and how patients respond to the treatment. You might be able to join if you are 18 or older and have progressive or recurrent glioblastoma that cannot be removed by surgery. This is an early-stage study with a small number of participants.

Study design
This is an early-phase interventional study with a planned enrollment of 8 participants. It is not specified if it's randomized or blinded.
What's involved
You would receive SONALA-001 intravenously or 5-ALA HCL orally, followed by MRgFUS on day 1 of each cycle. Cycles repeat every 42 days. You will also have blood tests, CT scans, and MRI scans throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 30 days after your last dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07076472

Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~8 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Aminolevulinic Acid Intravenous Formulation SONALA-001Biospecimen CollectionComputed TomographyElectronic Health Record ReviewMagnetic Resonance ImagingMRI-Guided Focused Ultrasound Ablation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 30 days after last dose of study treatment
+4 more outcomes measured

Conditions

Progressive Glioblastoma
Recurrent Glioblastoma

Explore related trials

Glioblastoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Terence C. Burns, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Diagnosis of recurrent or progressive glioblastoma (as defined in 2021 World Health Organization \[WHO\] Classification of Tumors of the Central Nervous System; Louis, Perry, et al. 2021) for which resection is not indicated as assessed by the study physician
Radiographic evidence of disease which may be measurable or non-measurable
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Previous treatment with radiotherapy (RT)
Have a life expectancy of ≥ 12 weeks
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
Albumin ≥ 3 g/dL (obtained ≤ 15 days prior to registration)
Potassium ≥ lower limit of normal (LLN) (obtained ≤ 15 days prior to registration)
Serum total calcium ≥ LLN (obtained ≤ 15 days prior to registration)
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Willing to participate in the neuro-oncology biorepository \[Institutional Review Board (IRB) 12-003458, principal investigator (PI): Jann Sarkaria, MD, PhD\] for collecting and archiving biospecimens samples on neuro-oncology patients
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion

Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
Recurrence ≤ 4 weeks after the completion of RT, defined from the imaging assessment immediately after completion of RT
Three or more prior systemic treatments for recurrent or progressing disease
Diagnosis of porphyria, or hypersensitivity to porphyrins
Failure to recover to grade 1 or baseline from any adverse events (AEs) (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5.0) related to prior anticancer therapy
EXCEPTIONS: Alopecia, lymphopenia, peripheral neuropathy, and ototoxicity ≤ grade 3)
Known history of the following conditions:
Allergy to gadolinium contrast agents
Patients known to be HIV positive and currently receiving antiretroviral therapy
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Inability to undergo MRI scans
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Patients with platelet count \< 100
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Or psychiatric illness/social situations that would limit compliance with study requirements
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

What this trial measures

  • Incidence of adverse events (AEs)Up to 30 days after last dose of study treatment

    Defined per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 as AEs considered to be at least possibly related to study treatment. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by dose level and overall).

  • Incidence of grade 3 or higher non-hematologic AEsUp to 30 days after last dose of study treatment

    Defined per the CTCAE v5 as AEs considered to be at least possibly related to study treatment. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by dose level and overall).

  • Incidence of grade 4 or higher AEUp to 30 days after last dose of study treatment

    Defined per the CTCAE v5 as AEs considered to be at least possibly related to study treatment. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by dose level and overall).

  • Dose-limiting event (DLE)During first 6 weeks of therapy [first cycle of treatment (cycle length = 42 days)]

    AEs will be evaluated using CTCAE v5. The target DLE rate is \< 33%.

  • Maximum tolerated dose (MTD)Up to 6 weeks

    Will be defined as the highest safety-tolerated dose level where at most one patient out of six experiences a DLE.