Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treat… (NCT05630209) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
United States10 participantsStarted 2023-01-04
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients
Who can participate
Age range5 Years – 21 Years
SexALL
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Inclusion Criteria:
* Age between 5 and 21 years, inclusive. Subjects younger than 5 years old may be eligible after discussion with the Sponsor Medical Monitor/designee (i.e. DSMB).
* Patient diagnosed with DIPG
* At least 4-week and not greater than 12 weeks from completion of radiation therapy
* Post-radiation imaging does not show evidence of necrosis/ hemorrhage or other features that contraindicate MRgFUS
* If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable
* If on steroids, stable or decreasing dose for at least 7 days prior to study entry
* Stable or improving neurologic status for 7 days prior to study entry
* Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
* Able to attend all study visits and with life expectancy of at least 6 months
Exclusion Criteria:
* Tumor not visible on any pre-therapy or post-radiation imaging
* Previous participation in other chemotherapy, molecularly targeted therapy, or immunotherapy treatment-related phase 1 or 2 trials
* Symptoms and signs of increased intracranial pressure
* Subject with metastatic disease
* Subject with ventricular peritoneal shunt
* Subject receiving bevacizumab (Avastin) therapy or increasing doses of steroids
* Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \[NSAIDs\], statins) within washout …