Summary

Eligibility
for people ages 5 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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

Official Title

A Phase 2 Dose-escalation Study Examining the Safety, Pharmacokinetics, and Preliminary Efficacy of Ascending Drug and Energy Dose Combinations for Sonodynamic Therapy Using SONALA-001 in Combination with Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in Subjects with Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma (DMG)

Keywords

Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, DIPG, Sonodynamic Therapy, Exablate 4000 Type 2.0, MR-guided Focused Ultrasound, SONALA-001, SDT, MRgFUS, Aminolevulinic acid HCI, ALA HCI, ALA, DMG, Glioma, SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)

Eligibility

Locations

  • UCSF
    San Francisco California 94143 United States
  • Children's National / Children's Research Institute
    Washington District of Columbia 20010-2916 United States
  • Nicklaus Children's Hospital
    Miami Florida 33155 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
SonALAsense, Inc.
ID
NCT05123534
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 15 people participating
Last Updated