Status:
ACTIVE_NOT_RECRUITING
Fetal Treatment of Galenic Malformations
Lead Sponsor:
Darren Orbach
Conditions:
Vein of Galen Malformations
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL ...
Eligibility Criteria
Inclusion
- 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
- 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 \<100.
- Medical disease requiring current anticoagulation including maternal deep vein thrombosis.
- Prior maternal medical history that would preclude epidural anesthesia.
- Multi-fetal pregnancy.
- Placenta previa or accreta.
- Participation in another fetal study that influences maternal and fetal morbidity and mortality.
- Known maternal hypersensitivity to 316LM stainless steel.
- Supine hypotensive syndrome.
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04434729
Start Date
September 30 2022
End Date
August 1 2026
Last Update
January 6 2026
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115