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A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG

NCT05123534 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

No results posted yet for this study

Summary

The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and 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 in subjects with diffuse intrinsic pontine glioma

Funding Source - FDA OOPD

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Midline Glioma

Interventions

COMBINATION_PRODUCT

SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)

SONALA-001(ALA) given 6-12 hours prior to receiving the MRgFUS.

Sponsors & Collaborators

  • SonALAsense, Inc.

    lead INDUSTRY

Principal Investigators

  • Corina Andresen, MD · SonALAsense, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2024-07-30
Completion
2024-10-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123534 on ClinicalTrials.gov