Rendering of patient receiving MRI treatment

Sonodynamic Therapy Phase 1/2 Clinical Trial For Recurrent Glioblastoma

About the glioblastoma
phase 1/2 clinical trial

The Ivy Brain Tumor Center at Barrow Neurological Institute is conducting a Phase 1/2 study of sonodynamic therapy (SDT) in patients with recurrent glioblastoma (rGBM).

The primary objectives of this nonsurgical study are to evaluate the safety and preliminary efficacy of SDT using SONALA-001 (ALA) and Exablate Type-2 device in patients with recurrent or progressive GBM.

Oral ALA is a drug currently used in patients with certain types of tumors to assist in tumor visualization and increase the amount of tumor resected during surgery. In this study, we will investigate the drug’s ability to make the tumor tissue more sensitive to ultrasound, ultimately slowing tumor growth.

Sonodynamic Therapy Phase 1/2 Clinical Trial Details

Study Status

Recruiting

Treatment Agent(s)

SONALA-001(ALA) and Exablate Type-2 MR-Guided Focused Ultrasound (MRgFUS)

Diseases

Recurrent or Progressive Glioblastoma

Estimated Enrollment

57 Participants 

Clinicaltrials.gov identifier
Study Sponsor
Older recurrent glioblastoma patient listening to her neuro-oncologist

You may be eligible if:

  • You are 18 years or older.
  • You have a histologically diagnosed primary glioblastoma that has recurred or progressed, and resection is not indicated.
  • You received previous first-line treatment with standard-of-care radiotherapy and temozolomide. Temozolomide is only required if the tumor has at least partial methylation of the MGMT promoter.

What to expect from Sonodynamic Therapy Phase 1/2 Clinical Trial for Recurrent Glioblastoma

Icon of Female receiving IV drip in recurrent glioblastoma clinical trial

The patient will receive a dose of SONALA-001 (aminolevulinic acid HCI, or ALA) using an intravenous (IV) catheter. The drug will be infused into the patient’s bloodstream for about 10 minutes.


Icon of patient receiving sonodynamic therapy in a recurrent glioblastoma clinical trial

Approximately 6-7 hours after receiving SONALA-001, the patient will receive an MRI and sonodynamic therapy. The Exablate Type-2 Device is used with an MRI (magnetic resonance imaging) to help direct the treatment to the tumor tissue. The MRI will also help monitor safety when using the device.


Recurrent glioblastoma brain tumor receiving focused ultrasound

Once the MRI confirms the tumor area to be targeted, the device will use ultrasound to apply pulses of energy to the tumor tissue until the entire targeted area has been treated. The Exablate Type-2 device may work with SONALA-001 to kill the tumor cells. This is called sonodynamic therapy or SDT.


Icon of doctor and glioblastoma patient in follow-up visit

After treatment, the patient will return for post-treatment assessments to evaluate the safety of the treatment and if it had any effects on the tumor. Depending on when the patient joins the study, they may have one, two, or three treatments given one month apart.


How Sonodynamic Therapy Works for Treating Recurrent Glioblastoma

Am I Eligible for a Sonodynamic Therapy Clinical Trial?

Submit a free trial screening request today to learn if you may qualify for this study or any others available at our center.

Neuro-oncologist writing on a notepad while discussing treatment options with glioblastoma patient

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