A Phase II Trial of Fetal Embolization for Vein of Galen Malformation

This is a prospective, single-arm non-randomized interventional study of fetuses to assess the efficacy and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.

Study Overview

• Status: Not yet recruiting
• Conditions: Vein of Galen Malformations
• Intervention / Treatment: Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils

Detailed Description

The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization for fetuses with vein of Galen malformations (VOGM) with a falcine sinus (FS) width of >= 7 mm (study population). Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix. This procedure will take place in an OR at Boston Children's Hospital. Data regarding pre-delivery, delivery and post-delivery status will be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed on the child every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darren Orbach, MD PhD; Phone Number: 617-355-5012; Email: Darren.Orbach@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Contact: Darren Orbach, MD; Phone Number: 617-355-5012; Email: darren.orbach@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; This is an open-label, single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.	Device: Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils; 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 Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of fetal embolization for patients with vein of Galen malformations	Primary outcome/endpoint: mortality measured from birth to day 30 of life.	Birth to day 30 of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of fetal embolization of patients with vein of Galen malformations	Safety outcomes/endpoint: the incidence of the following serious adverse events (SAEs) from Day 0 (the day of fetal intervention) till birth, as measured by number of events experienced across the number of participants enrolled: Fetal intraparenchymal hemorrhage with mass effect, likely related to the procedure; Fetal territorial ischemic infarct, likely related to the procedure; Procedure-related fetal hemorrhage, either intracranial or extracranial, requiring transfusion; Maternal hemorrhage requiring blood transfusion; Procedure-related placental injury requiring urgent Caesarian section	Day of fetal intervention to 24 months of age
Brain parenchymal injury	The incidence of brain parenchymal injury on the first postnatal scan will be collected and compared to a historical cohort that did not undergo fetal intervention.	Birth to first postnatal scan
Neurodevelopmental milestones at 6 months	A neurological assessment will be performed at 6 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test. Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.	Birth through 6 months
Neurodevelopmental milestones 6 months through 24 months	Neurological assessments will be performed from 6 months adjusted gestational age to 24 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test, Child Behavior Checklist, DAYC-2 cognitive assessment, and the Bayley examination (if seen in person). Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.	6 months through 24 months

Collaborators and Investigators

• Sponsor: Darren Orbach
• Investigators: Principal Investigator: Darren Orbach, MD PhD, Boston Children's Hospital, Boston, MA 02115

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Nervous System Malformations; Intracranial Arterial Diseases; Vascular Malformations; Arteriovenous Malformations; Central Nervous System Vascular Malformations; Intracranial Arteriovenous Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vein of Galen Malformations
• Other Study ID Numbers: P00052699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes