Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07076472

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

Led by Mayo Clinic · Updated on 2026-02-23

8

Participants Needed

1

Research Sites

72 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of recurrent or progressive glioblastoma without indication for surgical removal
  • Radiographic evidence of tumor which may be measurable or non-measurable
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Previous treatment with radiotherapy
  • Life expectancy of at least 12 weeks
  • Hemoglobin level of 9.0 g/dL or higher within 15 days before registration
  • Absolute neutrophil count of 1500/mm^3 or higher within 15 days before registration
  • Platelet count of 100,000/mm^3 or higher within 15 days before registration
  • Total bilirubin less than or equal to 1.5 times the upper limit of normal within 15 days before registration
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to 3 times the upper limit of normal (up to 5 times if liver involvement) within 15 days before registration
  • Albumin level of 3 g/dL or higher within 15 days before registration
  • Potassium level at or above the lower limit of normal within 15 days before registration
  • Serum total calcium at or above the lower limit of normal within 15 days before registration
  • Creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance of at least 60 mL/min within 15 days before registration
  • Negative pregnancy test within 8 days before registration for persons who can become pregnant
  • Provide written informed consent
  • Willing to participate in the neuro-oncology biorepository for biospecimen collection
  • Willing to return to the enrolling institution for follow-up during active monitoring
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential or able to father a child unwilling to use adequate contraception
  • Recurrence of glioblastoma within 4 weeks after completing radiotherapy
  • Having had 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 prior anticancer therapy-related adverse events, except for certain mild exceptions
  • Allergy to gadolinium contrast agents
  • Known HIV positive patients currently receiving antiretroviral therapy
  • Inability to undergo MRI scans
  • Uncontrolled illness including active infection, low platelet count below 100, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting study compliance
  • History of recent myocardial infarction (within 6 months) or congestive heart failure requiring ongoing maintenance therapy for life-threatening arrhythmias
  • Severe co-morbid systemic illnesses or other diseases that would interfere with safety assessment or study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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