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Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial

4. november 2026 opdateret af: Michael A Belfort

Fetal Embolization Via Transcardiac Transarterial Ultrasound and Fluoroscopy-guided Endovascular Surgery (FETTUS) for Severe Vein of Galen Malformation - A Feasibility and Safety Trial

The goal of this clinical trial is to evaluate the feasibility and safety of fetal embolization for severe, otherwise lethal, Vein of Galen Malformation (VOGM) via a laparotomy-assisted approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 participants. The hypothesis is that in utero embolization of severe VOGM will reduce postnatal mortality and morbidity in severe VOGM infants with minimal maternal risks and acceptably low fetal risks.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Participants will be offered the FETTUS technique as an alternative to the traditional standard postnatal VOGM embolization if all study criteria are met. During the surgery, the mother's uterus is exteriorized using the standard laparotomy approach that we currently use for our fetoscopic spina bifida repair and then transuterine fetal cardiac access is obtained under continuous ultrasound guidance. Once the needle is in place, a microcatheter is advanced through the blood vessels in the heart and up to the site of the malformation in the brain. The malformation will be embolized using medical-grade glue (Trufill n-BCA Liquid Embolic System, Johnson & Johnson)

All participants will be closely followed with postoperative ultrasound scans and consultations. Delivery will be scheduled at Texas Children's Hospital, and the infants will be followed by our research team until they reach 24 months of age.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Texas Children's Hospital
        • Underforsker:
          • William Whitehead, MD, MPH
        • Underforsker:
          • Luc Joyeux, MD, PhD
        • Underforsker:
          • Magdalena Sanz Cortes, MD, PhD
        • Underforsker:
          • Caitlin Sutton, MD
        • Kontakt:
          • Becky Johnson, MS
          • Telefonnummer: 832-826-7451
          • E-mail: rj2@bcm.edu
        • Kontakt:
          • Michael Belfort, MD, PhD
          • Telefonnummer: 832-826-7375
          • E-mail: belfort@bcm.edu
        • Underforsker:
          • Becky Johnson, MS, CCRP
        • Ledende efterforsker:
          • Michael Belfort, MD, PhD
        • Underforsker:
          • Karen Chen, MD
        • Underforsker:
          • Carolyn Altman, MD
        • Underforsker:
          • Jessian Munoz, MD, PhD, MPH
        • Underforsker:
          • Samuel McClugage, MD
        • Underforsker:
          • Howard Weiner, MD
        • Underforsker:
          • Dajana Sabic, DO
        • Underforsker:
          • Lisa Emrick, MD
        • Underforsker:
          • Larry Hollier, MD
        • Underforsker:
          • Thierry Huisman, MD, PhD
        • Underforsker:
          • David Mann, MD, DBe

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  1. Pregnant woman - maternal age 18 years or older

  2. Singleton pregnancy

  3. Prenatal sonographic evidence of Vein of Galen Malformation (VOGM) between 23-0/7 and 37-0/7 weeks of gestation

  4. VOGM volume ratio (VBR) >9.69% and narrowest mediolateral diameter of the straight or falcine sinus (>10.15 mm) on prenatal magnetic resonance imaging (MRI)

  5. Worsening VOGM severity on follow up prenatal imaging (i.e. ultrasound, MRI and/or echocardiography), and exceeding the specified threshold measurements in any one or more of the following prognostic markers: VOGM varix volume (≥10.9cm3), new or progressive middle cerebral artery pseudofeeders, and/or worsening combined cardiac index (CCI >750 mL/kg/min).

  6. Absence of bilateral extensive brain damage on fetal MRI

  7. Absence of significant* fetal anomalies unrelated to VOGM on fetal US and/or MRI imaging

  8. Gestational age at the time of the procedure will be between 30-0/7 and 37-0/7 weeks

  9. Negative maternal serological tests for HIV, Hepatitis B and Hepatitis C because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the pregnant woman's HIV status or Hepatitis status is unknown, she must be tested and found to have negative results before enrollment

  10. The pregnant woman has considered and declined termination of pregnancy

  11. The pregnant woman meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)

  12. Signed informed consent by participant and the father of the baby

    • Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the fetus.

Exclusion Criteria:

  1. Extensive fetal brain parenchymal injury or gliosis on fetal MRI, defined as greater than one quarter of supratentorial brain volume consistent with advanced irreversible brain injury
  2. Severe hydrops fetalis on fetal ultrasound, characterized by large-volume effusions resulting in organ compression, diffuse fetal skin edema, and marked cardiomegaly
  3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
  4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  5. Pre-pregnancy body-mass index (BMI) ≥40
  6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
  7. Technical limitations precluding fetal surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
  8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  9. Maternal medical condition that is a contraindication to surgery or anesthesia, i.e. any inadequately controlled maternal medical condition resulting in an American Society of Anesthesiologists (ASA) Physical Status classification of III or higher
  10. Low amniotic fluid volume (Amniotic Fluid Index less than 5cm), unresponsive to maternal hydration, if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture
  11. The pregnant woman does not have a support person (i.e., spouse, partner, family member, or close friend) available to support her for the duration of the pregnancy
  12. Inability to comply with the travel and follow-up requirements of the trial
  13. The pregnant woman has severe depression and has not been cleared by a psychiatrist
  14. The pregnant woman is enrolled or has been enrolled in any another intervention study that affects the mother or fetus
  15. Maternal contraindications to nonionic contrast agent such as acute thyroid dysfunction and acute kidney injury
  16. Maternal hypersensitivity to any of the entities associated with the use of nonionic contrast agent. The use of Omnipaque distributed by GE Healthcare company is contraindicated for participants sensitive to any of the components listed on the container package, i.e. Iohexol (Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide), edetate calcium disodium and tromethamine
  17. Maternal hypersensitivity to any of the entities associated with the use of liquid embolic system. The use of Trufill (n-BCA) distributed by Cerenovus - Johnson&Johnson company is contraindicated for participants sensitive to any of the components listed on the container, i.e. n-BCA, Ethiodized Oil and Tantalum Powder

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fetal Embolization

This is a single arm study in which participants will undergo a one-time intervention of fetal embolization for severe Vein of Galen Malformation.
Kombinationsprodukt: Fetal embolization of severe Vein of Galen Malformation using a liquid embolic system

Participants will undergo a laparotomy, exteriorization of the uterus, and uterine needle puncture to obtain fetal cardiac access so a catheter can be inserted into an artery and guided up to the site of the malformation. A liquid embolic system (Trufill n-Butyl CyanoAcrylate, Johnson & Johnson) will be used to occlude the dominant arterial pedicle supplying the shunt.

Andre navne:
  • FETTUS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From the date of fetal embolization until the date of discharge from the NICU, or the date of death from any cause, whichever came first, assessed up to 24 months

If the fetal survives to delivery and discharge from the neonatal intensive care unit (NICU)
From the date of fetal embolization until the date of discharge from the NICU, or the date of death from any cause, whichever came first, assessed up to 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of FETTUS in Cases of Severe Vein of Galen Malformation
Tidsramme: At the end of the fetal embolization procedure

If all of the following occurs:

  1. There is successful embolization of the target feeding artery
  2. The fetus survives through the end of the embolization procedure
At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At the end of the fetal embolization procedure

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Fetal Demise
  2. Fetal bradycardia/arrhythmia
  3. Hydrops fetalis
  4. Fetal intracranial hemorrhage
  5. Emergent delivery
At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At the end of the fetal embolization procedure

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Contrast agent (cumulative contrast dose)
  2. Cumulative radiation dose
At the end of the fetal embolization procedure
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Fetal demise
  2. Fetal intracranial hemorrhage
  3. Need for emergent delivery
From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Maternal length of stay (in days)
From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Intrauterine growth restriction (IUGR)
  2. Intrauterine fetal demise (IUFD)
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Gestational age at delivery
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Birth weight (grams)
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Bicêtre VOGM prognosis score (0-21)
  2. APGAR scores
  3. Number of events related to glue migration
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Umbilical artery pH
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At hospital discharge or date of death, whichever came first, assessed up to 24 months

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Neonatal or infant death
  2. Cardiac arrhythmia and/or reduced ejection fraction on echocardiography
  3. Focal neurological deficit
  4. Seizure
  5. Stroke (hemorrhagic vs. focal non-hemorrhagic)
  6. Global cortical atrophy or gliosis
  7. Delayed myelination
  8. Arteriovenous shunting
  9. Liver failure
  10. Renal failure
  11. Thyroid dysfunction
  12. Complications related to prematurity
At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At hospital discharge or date of death, whichever came first, assessed up to 24 months

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Number of events related to glue migration
At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At hospital discharge or date of death, whichever came first, assessed up to 24 months

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Duration of intubation (days)
  2. Time on pressors (in days)
  3. Time on treatment for pulmonary hypertension (in days)
  4. Time to initiation of enteral feeds (in days)
  5. Time on total parenteral nutrition (TPN) (in days)
  6. Length of hospital stay (in days)
At hospital discharge or date of death, whichever came first, assessed up to 24 months
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At 12 and 24 months of age

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

  1. Infant Death
  2. Need for additional embolizations
  3. Renal failure
  4. Thyroid dysfunction
  5. Stroke (hemorrhagic vs. focal non-hemorrhagic)
  6. Global cortical atrophy or gliosis
  7. Delayed myelination
  8. Arteriovenous shunting
  9. Hydrocephalus
  10. Focal neurological deficit
  11. Seizure
At 12 and 24 months of age
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: At 12 and 24 months of age

Fetal and infant morbidity and mortality will be assessed using the following outcomes:

Neurodevelopmental outcomes (Developmental Profile Assessment, Capute Scales, Revised Gesell Developmental Schedules)
At 12 and 24 months of age
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Maternal morbidity and mortality will be assessed using the following outcomes:

  1. Mortality
  2. Contrast-agent-related complications
  3. Anesthesia complications
  4. Pulmonary edema
  5. Need for blood transfusion
  6. Wound infection.
  7. Chorioamniotic membrane separation
  8. Chorioamnionitis
  9. Oligohydramnios
  10. Preterm labor
  11. Preterm delivery
  12. Preterm premature rupture of membranes
  13. Placental abruption
  14. Maternal postoperative readmission for a procedure-related complication
From date of fetal embolization to date of delivery, assessed up to 10 weeks
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
Tidsramme: From date of fetal embolization to date of delivery, assessed up to 10 weeks

Maternal morbidity and mortality will be assessed using the following outcomes:

Number of events related to glue migration
From date of fetal embolization to date of delivery, assessed up to 10 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Michael A Belfort

Samarbejdspartnere

Baylor College of Medicine

Efterforskere

  • Ledende efterforsker: Michael Belfort, MD, PhD, Baylor College of Medicine and Texas Children's Hospital
  • Studieleder: Luc Joyeux, MD, PhD, Baylor College of Medicine and Texas Children's Hospital
  • Studieleder: Karen Chen, MD, Baylor College of Medicine and Texas Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

1. december 2032

Studieafslutning (Anslået)

1. december 2035

Datoer for studieregistrering

Først indsendt

12. oktober 2026

Først indsendt, der opfyldte QC-kriterier

4. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-57171

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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