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Completed
NCT04434729
Fetal Treatment of Galenic Malformations
Conditions: Vein of Galen Malformations
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 7
Sponsor: Darren Orbach
Location: Boston Children's Hospital Boston Massachusetts
Summary
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Eligibility Criteria
Inclusion Criteria:
* Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal slice).
* Fetal gestational age between 23 weeks and term as determined by clinical information and evaluation of first ultrasound.
* Anatomic diagnosis of fetal vein of Galen malformation.
* Well preserved brain parenchyma.
* Maternal age of 18 years and older.
* Eligible for continuous lumbar epidural anesthesia.
* Able to travel to study site for study evaluation, procedures and visits.
Exclusion Criteria:
* Extensive fetal brain parenchymal injury/gliosis, \>10% of supratentorial brain volume (i.e., SFP presentation). This is a degree of fetal brain injury beyond which the risk of significant neurological morbidity is high, based on studies of prenatal ischemic stroke.
* Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation), i.e., SFP presentation.
* Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort.
* Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater.
* Fetuses with major congenital anomalies.
* Evidence of preterm labor, rupture of membranes or abruption.
* Maternal coagulopathy: INR \> 1.2; PT/PTT above normal ranges for the lab; platelets \
Source: ClinicalTrials.gov (NCT04434729). StuddyBuddy aggregates publicly available trial information.