Fetal embolization for vein of Galen malformation in late gestation
Official title: A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
Run by Boston Children's Hospital · NCT07483255 · Data updated 2026-11-12
This study tests a one-time fetal embolization procedure for babies with vein of Galen malformations when the fetus is at least 34 weeks along.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | December 2030 |
| Study ends | December 2032 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07483255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women carrying a fetus with vein of Galen malformation with a straight or falcine sinus diameter of 7 mm or more and a gestational age of 34 weeks or greater at planned intervention.
✕Probably not a fit
Patients whose fetal anatomy or positioning prevents safe access or those with non-appropriate anatomy or comorbidities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm interventional study enrolling fetuses with vein of Galen malformations and a dilated falcine sinus. The planned procedure uses transuterine, fetal transcranial access to embolize the malformation with detachable platinum coils during late pregnancy at Boston Children's Hospital. Neurological follow-up for the child is planned every 6 months for two years after birth, with results compared to historical cohorts. Data collection includes pre-delivery, delivery, and post-delivery status to assess safety and potential benefits. The study is non-randomized and lacks a control group.
Why it matters
Potential benefit: If successful, the approach could reduce brain injury risk and improve neurodevelopmental outcomes for affected infants.
How similar studies have gone: Previous work in fetal vascular interventions has shown potential benefits in selected cases, but this exact approach for VOGM is novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 or axial slice). 2. Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of first ultrasound. The suitability for fetal treatment, in terms of technical/positional factors, will be assessed on a case-by-case basis by the MFM, ultrasonographer, and neurointerventionalist participating in the study. 3. Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous fistula, can result in dilated intracranial vascular structures being visualized in utero. Similarly, fetal dilatation of the vein of Galen can occasionally be seen without the presence of an arteriovenous lesion at all, as a benign venous variant. This condition is readily distinguishable sonographically from VOGM by virtue of the presence of dilated arterial feeding pedicles, and by the presence of an arterial waveform within the varix. This study is aimed solely at fetuses with an established diagnosis of vein of Galen malformation. Exclusion Criteria: 1. Extensive fetal brain parenchymal injury/gliosis, i.e. \>10% of supratentorial brain volume (SFP presentation). In some cases, significant bihemispheric cerebral parenchymal injuries are seen at the time of initial fetal diagnosis of vein of Galen malformation (SFP cohort). Such fetuses rarely survive, but if they do, are profoundly neurodevelopmentally impaired: typically blind, mute, quadriparetic, often with unremitting intractable seizures, and permanently bed-bound and uncommunicative. As there is no realistic possibility of achieving a good neurological outcome in such patients, fetuses with diffuse bihemispheric brain injury will be excluded. 2. 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). 3. 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 or axial 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 4. Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater 5. Fetuses with major extracranial congenital anomalies 6. Evidence of preterm labor, rupture of membranes or abruption 7. Maternal coagulopathy: INR \> 1.2; PT/PTT above normal ranges for the lab; platelets \<100 8. Any maternal use of anticoagulants, whether prophylactic or therapeutic. 9. Prior maternal medical history that would preclude epidural anesthesia 10. Multi-fetal pregnancy 11. Placenta previa or accreta 12. Participation in another fetal study that influences maternal and fetal morbidity and mortality 13. Known maternal hypersensitivity to 316LM stainless steel 14. Supine hypotensive syndrome
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Darren Orbach, MD PhD — Boston Children's Hospital, Boston, MA 02115
- Study coordinator: Darren Orbach, MD PhD
- Email: Darren.Orbach@childrens.harvard.edu
- Phone: 617-355-5012
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.