Progressive GlioblastomaEarly Phase 1NCT07076472
Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma
A Early Phase 1 study testing Aminolevulinic Acid Intravenous Formulation SONALA-001, Biospecimen Collection and Computed Tomography in people with Progressive Glioblastoma and Recurrent Glioblastoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Glioblastoma, Recurrent Glioblastoma
- What is being tested?
- Aminolevulinic Acid Intravenous Formulation SONALA-001, Biospecimen Collection and Computed Tomography
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 31 Dec 2031
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, mayocliniccancerstudies@mayo.edu
Terry Burns, MD, PhD
About this study
Official title: MC240704 Pilot Dose Escalation and Expansion Study of Sonodynamic Therapy With Aminolevulinic Acid Hydrochloride (5-ALA HCl Or SONALA-001) in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (RGBM)
This early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To characterize the safety and toxicity after treatment with aminolevulinic acid intravenous formulation SONALA-001 (SONALA-001) or orally administered aminolevulinic acid hydrochloride (5-ALA HCL) in combination with MRgFUS in subjects with progressive or recurrent glioblastoma (rGBM).
SECONDARY OBJECTIVES:
- To evaluate the preliminary antitumor activity as assessed by objective response rate (ORR; proportion of patients with complete or partial response) per Response Assessment in Neuro-Oncology (RANO) 2.0 guidelines.
II. To evaluate preliminary signals of activity as measured by clinical benefit rate (CBR) (proportion of patients with complete response, partial response or stable disease), progression-free survival (PFS), PFS rate at 6 months, and overall survival (OS).
OUTLINE:
Patients receive SONALA-001 intravenously (IV) over 15 minutes or 5-ALA HCL orally (PO) and undergo transcranial MRgFUS 3-8 hours after infusion on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a computed tomography (CT) of the brain prior to treatment and blood sample collection and magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at 30 days, and then every 3 to 6 months for up to 3 years after registration.
- Conditions
- Progressive Glioblastoma, Recurrent Glioblastoma
- Being tested
- Aminolevulinic Acid Intravenous Formulation SONALA-001, Biospecimen Collection, Computed Tomography, Electronic Health Record Review, Magnetic Resonance Imaging
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid Intravenous Formulation SONALA-001Drug
Also called ALA Intravenous Formulation SONALA-001, SONALA 001, SONALA-001, SONALA001
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
MRI-Guided Focused Ultrasound AblationProcedure or surgery
Also called Magnetic Resonance Imaging-guided High-Intensity Focused Ultrasound, Magnetic Resonance-guided Focused Ultrasound, MR-HIFU, MRgFUS
Undergo transcranial MRgFUS
Oral Aminolevulinic Acid HydrochlorideDrug
Also called 5-ALA fluorescence, 5-Aminolevulinic Acid Hydrochloride, 5-Aminolevulinic Acid Hydrochloride, Oral, Gleolan
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SONALA-001, MRgFUS) | Experimental | Patients receive SONALA-001 IV over 15 minutes or 5-ALA HCL PO and undergo transcranial MRgFUS 3-8 hours after infusion on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a CT of the brain prior to treatment and blood sample collection and MRI throughout the study. Receives: Drug: Aminolevulinic Acid Intravenous Formulation SONALA-001; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Procedure: MRI-Guided Focused Ultrasound Ablation; Drug: Oral Aminolevulinic Acid Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
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).
Measured: Up to 30 days after last dose of study treatment
Incidence of grade 3 or higher non-hematologic AEs
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).
Measured: Up to 30 days after last dose of study treatment
Incidence of grade 4 or higher AE
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).
Measured: Up to 30 days after last dose of study treatment
Dose-limiting event (DLE)
AEs will be evaluated using CTCAE v5. The target DLE rate is < 33%.
Measured: During first 6 weeks of therapy [first cycle of treatment (cycle length = 42 days)]
Maximum tolerated dose (MTD)
Will be defined as the highest safety-tolerated dose level where at most one patient out of six experiences a DLE.
Measured: Up to 6 weeks
Secondary outcomes (8)
Overall response rate (ORR)
Assessed by the proportion of patients with complete or partial response.
Measured: Up to 3 years
Clinical benefit rate
Assessed by the proportion of patients with complete response, partial response or stable disease.
Measured: Up to 3 years
Progression-free survival (PFS)
Defined as the time from registration to the earliest date of documentation of disease progression, relapse, or death due to any cause.
Measured: Up to 3 years
PFS at 6 months (PFS6)
The PFS6 rate will be estimated as the number of patients who are progression-free and alive at 6 months.
Measured: At 6 months
Overall survival (OS)
Defined as the time from registration to death due to any cause.
Measured: Up to 3 years
Time to response
Defined as the time from registration to the first incidence of a response, estimated in patients who have achieved a response (PR or CR).
Measured: Up to 3 years
Duration of response
Defined as the time from response to progression or death, whichever occurs first estimated among patients who have achieved objective response (PR or CR).
Measured: Up to 3 years
Duration of clinical benefit
Defined as the time from response to progression or death, whichever occurs first, estimated among patients who achieved clinical benefit (stable disease, PR, or CR).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start14 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive GlioblastomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Terence C. Burns, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076472
- Sponsor's protocol ID
- MC240704
- Other IDs
- NCI-2025-04501, 24-013192, MC240704, R44CA275508
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC240704 Pilot Dose Escalation and Expansion Study of Sonodynamic Therapy With Aminolevulinic Acid Hydrochloride (5-ALA HCl Or SONALA-001) in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (RGBM)
- ClinicalTrials.gov ID
- NCT07076472
- Acronym / sponsor ID
- MC240704
- Conditions
- Progressive Glioblastoma, Recurrent Glioblastoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 22 Jul 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 early phase I trial tests the safety, best dose, and effectiveness of SONALA-001 or 5-ALA HCL in combination with magnetic resonance imaging-guided focused ultrasound (MRgFUS), also called sonodynamic therapy, in treating patients with glioblastoma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). Sonodynamic therapy is a non-invasive combination therapy that uses low-intensity ultrasound, such as MRgFUS, to activate a drug, such as SONALA-001 or 5-ALA HCL, to kill tumor cells. SONALA-001 or 5-ALA HCL binds to the tumor and may help the sonodynamic therapy target the tumor. MRgFUS is an image-guided, non-invasive technique that uses high energy ultrasound from the Exablate 4000 Type 2.0 device to kill tumors without damaging surrounding healthy tissue. Giving sonodynamic therapy using SONALA-001 or 5-ALA HCL with MRgFUS may be safe, tolerable, and/or effective in treating patients with progressive or recurrent glioblastoma.
Detailed description
PRIMARY OBJECTIVE:
- To characterize the safety and toxicity after treatment with aminolevulinic acid intravenous formulation SONALA-001 (SONALA-001) or orally administered aminolevulinic acid hydrochloride (5-ALA HCL) in combination with MRgFUS in subjects with progressive or recurrent glioblastoma (rGBM).
SECONDARY OBJECTIVES:
- To evaluate the preliminary antitumor activity as assessed by objective response rate (ORR; proportion of patients with complete or partial response) per Response Assessment in Neuro-Oncology (RANO) 2.0 guidelines.
II. To evaluate preliminary signals of activity as measured by clinical benefit rate (CBR) (proportion of patients with complete response, partial response or stable disease), progression-free survival (PFS), PFS rate at 6 months, and overall survival (OS).
OUTLINE:
Patients receive SONALA-001 intravenously (IV) over 15 minutes or 5-ALA HCL orally (PO) and undergo transcranial MRgFUS 3-8 hours after infusion on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a computed tomography (CT) of the brain prior to treatment and blood sample collection and magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at 30 days, and then every 3 to 6 months for up to 3 years after registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SONALA-001, MRgFUS) | Experimental | Drug: Aminolevulinic Acid Intravenous Formulation SONALA-001, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Electronic Health Record Review, Procedure: Magnetic Resonance Imaging, Procedure: MRI-Guided Focused Ultrasound Ablation, Drug: Oral Aminolevulinic Acid HydrochloridePatients receive SONALA-001 IV over 15 minutes or 5-ALA HCL PO and undergo transcranial MRgFUS 3-8 hours after infusion on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo a CT of the brain prior to treatment and blood sample collection and MRI throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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)
Key exclusion criteria (23 listed)
- 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:
- 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
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 Intravenous Formulation SONALA-001Also: ALA Intravenous Formulation SONALA-001, SONALA 001, SONALA-001, SONALA001Given IV | Drug | Treatment (SONALA-001, MRgFUS) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (SONALA-001, MRgFUS) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (SONALA-001, MRgFUS) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (SONALA-001, MRgFUS) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (SONALA-001, MRgFUS) |
| MRI-Guided Focused Ultrasound AblationAlso: Magnetic Resonance Imaging-guided High-Intensity Focused Ultrasound, Magnetic Resonance-guided Focused Ultrasound, MR-HIFU, MRgFUSUndergo transcranial MRgFUS | Procedure or surgery | Treatment (SONALA-001, MRgFUS) |
| Oral Aminolevulinic Acid HydrochlorideAlso: 5-ALA fluorescence, 5-Aminolevulinic Acid Hydrochloride, 5-Aminolevulinic Acid Hydrochloride, Oral, GleolanGiven PO | Drug | Treatment (SONALA-001, MRgFUS) |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 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 AEs
Time frame: Up 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 AE
Time frame: Up 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)
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 3 years
Clinical benefit rate
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
PFS at 6 months (PFS6)
Time frame: At 6 months
Overall survival (OS)
Time frame: Up to 3 years
Time to response
Time frame: Up to 3 years
Duration of response
Time frame: Up to 3 years
Duration of clinical benefit
Time frame: Up to 3 years
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 25 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Terence C. Burns, MD, PhD principal investigator
Mayo Clinic
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 Aminolevulinic Acid Intravenous Formulation SONALA-001, Biospecimen Collection and Computed Tomography in people with Progressive Glioblastoma and Recurrent Glioblastoma, run by Mayo Clinic 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 19 inclusion and 23 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 25 Aug 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?
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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Up to 30 days after last dose of study treatment). The study lists 5 primary outcomes in all. 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 25 Aug 2026.