Fetal Embolization for Vein of Galen Malformation

Overseen By Darren Orbach, MD PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Darren Orbach

Must not be taking: Anticoagulants

Disqualifiers: Severe obesity, Congenital anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulation medication, you may not be eligible to participate.

What data supports the effectiveness of this treatment for vein of Galen malformation?

Research shows that using embolization techniques, like detachable coils, has improved survival rates in infants with vein of Galen malformations. In one study, 6 out of 8 infants treated with these methods survived, compared to none who underwent older surgical techniques. ^{1 2 3 4 5}

Is fetal embolization for vein of Galen malformation safe?

Recent studies show that improvements in embolization techniques have led to better outcomes, with no mortality in a recent series of 11 patients and most patients being functionally normal at follow-up. However, there is still a risk of severe neurological deficits and developmental delays in some cases. ^{2 4 6 7 8}

How does the treatment with Target XL and XXL Detachable Coils differ from other treatments for vein of Galen malformation?

The treatment using Target XL and XXL Detachable Coils is unique because it involves a minimally invasive procedure called embolization, where coils are used to block abnormal blood flow in the vein of Galen. This approach is less invasive compared to traditional surgery and has shown improved outcomes in neonates with this condition, reducing mortality and severe complications. ^{1 3 4 6 9}

What is the purpose of this trial?

This trial tests a one-time procedure to treat fetuses with abnormal brain blood vessels using tiny coils. It aims to help fetuses with Vein of Galen Malformation, a condition that can cause serious health problems. The coils block the abnormal vessels to prevent complications.

Research Team

Darren Orbach, MD PhD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for pregnant women with a fetus diagnosed with Vein of Galen Malformation (VOGM), where the affected sinus measures at least 8 mm. The mother must be over 18, able to travel for study visits, and have a well-preserved fetal brain structure. Exclusions include preterm labor risks, maternal coagulopathy or diseases requiring anticoagulation, prior conditions preventing epidural anesthesia, multiple pregnancies, placenta issues, other conflicting studies participation, metal hypersensitivity and severe obesity.

Inclusion Criteria

I am pregnant and my fetus has a specific brain vessel malformation diagnosed by MRI.

I am a candidate for continuous lower back pain relief through an epidural.

My brain tissue is healthy.

Exclusion Criteria

You are showing signs of early labor, water breaking, or separation of the placenta.

Unborn babies with a specific type of brain blood vessel abnormality that measures less than 8 mm on a special type of MRI test will not be included in the study.

Unborn babies with serious birth defects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetal Intervention

A one-time fetal embolization procedure is performed using maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization.

1 day

1 visit (in-person)

Prenatal Follow-up

Data is collected every 4 weeks post-procedure until delivery to monitor safety and efficacy.

Until delivery

Every 4 weeks (in-person)

Postnatal Follow-up

Neurological assessments are performed every 6 months for 2 years after delivery to monitor long-term outcomes.

2 years

Every 6 months (in-person)

Treatment Details

Interventions

• Target XL and XXL Detachable Coils

Trial Overview The trial tests fetal embolization using Target XL and XXL Detachable Coils on fetuses with VOGM to evaluate safety and effectiveness. It's a single-arm study comparing results against historical data. Participants undergo one-time embolization followed by regular check-ups until delivery and neurological assessments every six months post-delivery for two years.

Participant Groups

Group I: Fetal embolization of vein of Galen malformation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Darren Orbach

Lead Sponsor

Trials

1

Recruited

30+

References

1. United States pubmed.ncbi.nlm.nih.gov

Interventional neuroradiological management of vein of Galen malformations in the neonate. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Fetal and Neonatal MRI Predictors of Aggressive Early Clinical Course in Vein of Galen Malformation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic disturbances associated with endovascular embolization in newborn infants with vein of Galen malformation. [2007]

4. China pubmed.ncbi.nlm.nih.gov

Transarterial embolisation with Guglielmi detachable coils in an infant with a vein of Galen aneurysmal malformation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Endovascular Treatment of Vein of Galen Malformations: A Systematic Review and Meta-Analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Recent improvement in outcome using transcatheter embolization techniques for neonatal aneurysmal malformations of the vein of Galen. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cross-sectional study of a United Kingdom cohort of neonatal vein of galen malformation. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Successful treatment of neonatal aneurysmal dilatation of the vein of Galen: the role of prenatal diagnosis and trans-arterial embolization. [2019]