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Sonodynamic Therapy

Sonodynamic Therapy for Brain Tumor

Phase 2
Recruiting
Led By Stuart Marcus, MD
Research Sponsored by SonALAsense, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DIPG Subjects: Must have stable to improved imaging by RAPNO (subjects ≤ 21 years of age) and mRANO (subjects > 21 years of age) criteria comparing the scan obtained post radiotherapy to the scan obtained during the screening period
DMG Subjects: Radiological diagnosis of Diffuse Midline Glioma (DMG) with tumor involving the pons, thalami, cerebellum, and/or molecular confirmation of H3K27M mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 24 hours post sonala-001 dosing
Awards & highlights

Study Summary

This trial is testing a new treatment for brain tumors called sonodynamic therapy. The goal is to find out if it is safe and tolerable for patients, and to determine the maximum amount of energy that can be used with this treatment.

Who is the study for?
This trial is for patients with a brain tumor called diffuse intrinsic pontine glioma (DIPG) who have finished radiotherapy at least 4 weeks ago but not more than 24 weeks ago and are stable or improved since then. They must be over the age of 5, unless approved by the medical monitor, and have normal organ function. Pregnant women can't join, and participants need to agree to use effective birth control.Check my eligibility
What is being tested?
The study tests sonodynamic therapy using SONALA-001 combined with an MR-Guided Focused Ultrasound device on DIPG patients. It aims to find out how safe this treatment is and what's the highest dose that patients can tolerate without severe side effects.See study design
What are the potential side effects?
Potential side effects may include reactions related to light sensitivity due to SONALA-001, discomfort from wearing the ultrasound device during treatment sessions, headache or dizziness post-treatment, skin irritation around the treated area, nausea or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor scans after radiotherapy are stable or better compared to before treatment.
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My brain tumor is in the middle of my brain or has a specific genetic change.
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I am 5 years old or older.
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I have a newly diagnosed brainstem tumor without spread, confirmed by imaging.
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I am at least 5 years old.
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I have received at least 54 Gy of radiation over 42-49 days for my brain tumor.
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My health allows me to do more than half of my usual activities.
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I am a woman who can have children and have a negative pregnancy test.
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My brain tumor scans after radiotherapy show no worsening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 24 hours post sonala-001 dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 24 hours post sonala-001 dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 (SDT) in subjects with DIPG.
To evaluate the safety and tolerability of SDT in DIPG subjects to generate data that will aid in the design of a larger Phase 2b trial.
Secondary outcome measures
Duration of response (DOR)
Overall survival (OS)
Preliminary efficacy, including objective response rate (ORR); Response Assessment in Pediatric Neuro-Oncology (RAPNO); Modified Response Assessment in Neuro-Oncology (mRANO).
+3 more
Other outcome measures
Duration of response (DOR) in the DMG subjects.
Overall survival (OS) in the DMG subjects.
Progression-free survival (PFS) in the DMG subjects.
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5 - DMG Cohort at RP2DExperimental Treatment1 Intervention
The RP2D of SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy
Group II: Cohort 4 - DIPG Cohort at RP2DExperimental Treatment1 Intervention
The RP2D of SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy
Group III: Cohort 3Experimental Treatment1 Intervention
10 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 3
Group IV: Cohort 2Experimental Treatment1 Intervention
5 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 2
Group V: Cohort 1Experimental Treatment1 Intervention
5 mg/kg IV SONALA-001 (ALA) and MR-guided Focused Ultrasound (MRgFUS) Energy Level 1

Find a Location

Who is running the clinical trial?

SonALAsense, Inc.Lead Sponsor
3 Previous Clinical Trials
438 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
400 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Corina Andresen, MDStudy DirectorSonALAsense, Inc.
2 Previous Clinical Trials
47 Total Patients Enrolled
Stuart Marcus, MDPrincipal InvestigatorSonALAsense, Inc.

Media Library

SONALA-001 and Exablate 4000 Type 2 (Sonodynamic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05123534 — Phase 2
Diffuse Intrinsic Pontine Glioma Research Study Groups: Cohort 1, Cohort 5 - DMG Cohort at RP2D, Cohort 3, Cohort 2, Cohort 4 - DIPG Cohort at RP2D
Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: SONALA-001 and Exablate 4000 Type 2 Highlights & Side Effects. Trial Name: NCT05123534 — Phase 2
SONALA-001 and Exablate 4000 Type 2 (Sonodynamic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123534 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sum of participants engaged in this clinical research?

"This research study necessitates 18 individuals meeting the eligibility criteria to partake in the trial. The two key locations of involvement are University of California, San Francisco in San Francisco and Children's National /Children's Research Institute in Washington D.C.."

Answered by AI

Are there still openings to participate in this experiment?

"Evidence from clinicaltrials.gov indicates that this medical trial is currently recruiting participants, with its initial posting on August 15th 2022 and the most recent update being November 3rd 2022."

Answered by AI

Is the SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS) sanctioned by the FDA?

"Our analysis at Power gave SONALA-001 (ALA) and MR-Guided Focused ultrasound device (MRgFUS) a score of 2, as this trial is only in Phase 2. Although there are some data to suggest safety, efficacy has yet to be established."

Answered by AI

What objectives does this research endeavor hope to achieve?

"This medical trial, due to be evaluated between Day 1 and 29, aims to assess the security of ALA SDT. Secondary objectives include determining Progression-free Survival (time from first dose until death or progression), Duration of Response (date of CR/PR till death or progression) as well as Area Under Concentration Time Curve (plasma samples collected 10 times pre/post SONALA-001)."

Answered by AI

Who else is applying?

How old are they?
< 18
What site did they apply to?
University of California, San Francisco
Children's National / Children's Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG
2022. "A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123534.
~5 spots leftby Aug 2024
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