Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treat… (NCT05615623) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
Canada10 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 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients
Who can participate
Age range5 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 5 and 18 years, inclusive
* 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
* Able to attend all study visits and with life expectancy of at least 6 months
* Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
* If on steroids, stable or decreasing dose for at least 7 days prior to study entry
* If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable
Exclusion Criteria:
* Evidence of cranial or systemic infection
* Known life-threatening systemic disease
* Previous treatment with complete cumulative doses of Doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
* Contraindication to Doxorubicin. - Known sensitivity to DEFINITY® ultrasound contrast agent or known hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol. - Known sensitivity to gadolinium-based contrast agents
* Active seizure disorder or epilepsy (seizures despite medical treatment) for a minimum of 4 weeks prior to first cycle/Exablate BBBD procedure captured by history
* Patients with positive HIV status. - Immunosuppression (corticosteroids to prevent/treat brain edema are permitted)
* Cerebral or …