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| Diagnosis | Brain Tumor | Study Status | Open |
| Phase | I/II |
| Age | 5 Years to 18 Years | Randomisation | NO |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Device: Exablate Model 4000 Type 2.0/2.1
Drug: Doxorubicin |
| Last Posted Update | 2023-06-26 |
| ClinicalTrials.gov # | NCT05615623 |
International Sponsor
InSightecPrincipal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids) - Dr. James RutkaCentres
Study Description
The purpose of this study is to evaluate the safety and efficacy of combining Focused Ultrasound (Exablate Model 4000 Type 2.0/2.1) with Doxorubicin therapy for the treatment of DIPG in pediatric patients.
Inclusion Criteria
- Age between 5 and 18 years, inclusive
- Patient diagnosed with DIPG
- Must be between 4-12 weeks from completion of radiation therapy
- Able to attend all study visits
- Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
- If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable
Additional inclusion and exclusion criteria may be discussed with you by the study team.
