search
Back to results

Fetal Treatment of Galenic Malformations

Primary Purpose

Vein of Galen Malformations

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
Sponsored by
Darren Orbach
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vein of Galen Malformations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 8 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 8 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.

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fetal embolization of vein of Galen malformation

Arm Description

This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.

Outcomes

Primary Outcome Measures

Prenatal safety of fetal embolization for patients with vein of Galen malformations
The procedure is deemed safe if None of the following unacceptable events occur within 7 days of fetal embolization: Fetal death Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage. Maternal death None of the following unacceptable events occur between fetal embolization and delivery: Intra-procedural and post-procedural morbidity to the fetus and mother Failure of progression of the pregnancy to term (or expected delivery date, as determined by the obstetrician) Preterm delivery due to abruption, infection, rupture of membranes or contractions Maternal blood transfusion or unanticipated surgical intervention Presence of fetal imaging evidence of new brain injury other than hemorrhage

Secondary Outcome Measures

Efficacy of fetal embolization for patients with vein of Galen malformations
The procedure is deemed efficacious if none of the following serious postnatal events occur within 30 days of birth: Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention. Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort. Brain MRI within the first three weeks after birth reveals parenchymal brain injury (acute infarct or gliosis) affecting > 10% of the supratentorial brain volume. Without fetal intervention, we'd expect 30% of patients in this cohort to show this kind of injury.

Full Information

First Posted
June 13, 2020
Last Updated
January 9, 2023
Sponsor
Darren Orbach
search

1. Study Identification

Unique Protocol Identification Number
NCT04434729
Brief Title
Fetal Treatment of Galenic Malformations
Official Title
Fetal Treatment of Galenic Malformations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darren Orbach

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix. This procedure will take place in an obstetric OR at Brigham and Women's Hospital. Data will be collected every 4 weeks post-procedure until delivery, as per standard of care. Data regarding delivery and post-delivery status will also be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vein of Galen Malformations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fetal embolization of vein of Galen malformation
Arm Type
Experimental
Arm Description
This is a single-arm study. Fetal subjects will undergo a one-time intervention of fetal embolization of vein of Galen malformation.
Intervention Type
Device
Intervention Name(s)
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
Intervention 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 Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.
Primary Outcome Measure Information:
Title
Prenatal safety of fetal embolization for patients with vein of Galen malformations
Description
The procedure is deemed safe if None of the following unacceptable events occur within 7 days of fetal embolization: Fetal death Fetal intracranial hemorrhage, either parenchymal or extra-axial, other than petechial hemorrhage. Maternal death None of the following unacceptable events occur between fetal embolization and delivery: Intra-procedural and post-procedural morbidity to the fetus and mother Failure of progression of the pregnancy to term (or expected delivery date, as determined by the obstetrician) Preterm delivery due to abruption, infection, rupture of membranes or contractions Maternal blood transfusion or unanticipated surgical intervention Presence of fetal imaging evidence of new brain injury other than hemorrhage
Time Frame
From fetal embolization to delivery
Secondary Outcome Measure Information:
Title
Efficacy of fetal embolization for patients with vein of Galen malformations
Description
The procedure is deemed efficacious if none of the following serious postnatal events occur within 30 days of birth: Urgent neonatal embolization is needed. Without fetal intervention, we'd expect 80% of the cohort to require such intervention. Neonatal death. Without fetal intervention, we'd expect a mortality rate of 40% in this cohort. Brain MRI within the first three weeks after birth reveals parenchymal brain injury (acute infarct or gliosis) affecting > 10% of the supratentorial brain volume. Without fetal intervention, we'd expect 30% of patients in this cohort to show this kind of injury.
Time Frame
Within 30 days of birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 8 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 8 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darren Orbach, MD PhD
Phone
617-355-5012
Email
Darren.Orbach@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Orbach, MD PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Orbach, MD PhD
Phone
617-355-5012
Email
Darren.Orbach@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Darren Orbach, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35613814
Citation
See AP, Wilkins-Haug LE, Benson CB, Tworetzky W, Orbach DB. Percutaneous transuterine fetal cerebral embolisation to treat vein of Galen malformations at risk of urgent neonatal decompensation: study protocol for a clinical trial of safety and feasibility. BMJ Open. 2022 May 24;12(5):e058147. doi: 10.1136/bmjopen-2021-058147.
Results Reference
derived

Learn more about this trial

Fetal Treatment of Galenic Malformations

We'll reach out to this number within 24 hrs