What is the mechanism of action of this treatment?

The most common treatment for Vein of Galen Malformation (VOGM) is endovascular embolization, which involves inserting materials to block abnormal blood flow within the malformed vessels. This procedure aims to reduce the high blood flow that can lead to heart failure and other complications. By occluding the abnormal vessels, embolization helps to normalize blood circulation and reduce the risk of hydrocephalus and other systemic issues. This is particularly important for VOGM patients as it can significantly improve survival rates and neurological outcomes, especially when performed early, such as in fetal interventions.

What side effects are associated with this type of intervention?

Endovascular embolization, the primary treatment for Vein of Galen Malformation, can have several side effects and complications. These include the risk of hemorrhage, injury to the central nervous system, and potential complications from the procedure itself, such as infection or adverse reactions to the embolic materials. The treatment aims to minimize these risks through careful and staged embolization to encourage graded thrombosis. Despite these risks, the prognosis with endovascular embolization is generally better than with traditional surgical methods.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals or related drugs for the treatment of Vein of Galen Malformation in the provided context. However, the primary treatment approach for this condition has been endovascular embolization, which involves blocking abnormal blood flow. This technique is similar to the fetal embolization being studied in the trial and has been the mainstay of treatment for managing Vein of Galen Malformations.

What other types of research exist?

Promising novel alternatives to fetal embolization for Vein of Galen Malformation patients include transarterial and transvenous embolization techniques. The use of adenosine-induced cardiac standstill has also shown to be well-tolerated and effective in pediatric patients. These methods have evolved significantly, offering improved outcomes and reduced risks compared to traditional surgical approaches.

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Vascular Embolization Device

Fetal Embolization for Vein of Galen Malformation

N/A

Waitlist Available

Led By Darren Orbach, MD PhD

Research Sponsored by Darren Orbach

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age of 18 years and older

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)

Must not have

Medical disease requiring current anticoagulation including maternal deep vein thrombosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of birth

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications from the embolization procedure such as bleeding or damage to surrounding tissues in the fetus or adverse reactions related to the coils used in treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

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My unborn baby has been diagnosed with a vein of Galen malformation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on blood thinners for a medical condition, like a deep vein thrombosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from fetal embolization to delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from fetal embolization to delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from fetal embolization to delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prenatal safety of fetal embolization for patients with vein of Galen malformations

Secondary study objectives

Efficacy of fetal embolization for patients with vein of Galen malformations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fetal embolization of vein of Galen malformationExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Vein of Galen Malformation (VOGM) is endovascular embolization, which involves inserting materials to block abnormal blood flow within the malformed vessels. This procedure aims to reduce the high blood flow that can lead to heart failure and other complications. By occluding the abnormal vessels, embolization helps to normalize blood circulation and reduce the risk of hydrocephalus and other systemic issues. This is particularly important for VOGM patients as it can significantly improve survival rates and neurological outcomes, especially when performed early, such as in fetal interventions.

Interventional neuroradiological management of vein of Galen malformations in the neonate.Primer of vein of galen malformation management.Outcome and complications of endovascular embolization for vein of Galen malformations: a systematic review and meta-analysis.