Study Name: Fetal Intervention for Vein of Galen Malformation
Principal Investigator: Darren Orbach, MD PhD, Boston Children's Hospital Cerebrovascular Surgery & Interventions Center / Maternal Fetal Care Center, firstname.lastname@example.org
Collaborating Investigator(s) Sought: No
Patients Sought: Candidates must have an in utero anatomic diagnosis of vein of Galen malformation, must be between 23 weeks and term gestational age, and must have well preserved brain parenchyma. Fetal MRI will be used to screen for appropriate subjects for the study. We will enroll 20 subjects on this trial.
Additional Information: We are conducting a clinical trial that may be of interest to you and your patients. This is a prospective, single-arm non-randomized study to assess the safety and efficacy of fetal embolization of vein of Galen malformations. As opposed to neonatal embolization, we believe that achieving flow diminution through the malformation by partial occlusion of the venous varix in utero would preempt development of pulmonary hypertension and likely protect both brain and heart from steal-related ischemia. As an additional benefit, morbidity to lower-extremity arteries from femoral catheterization in small infants would be avoided. Moreover, as prenatal treatment would be performed under ultrasound rather than fluoroscopy, procedural exposure to ionizing radiation would also be avoided.
Boston Children’s Hospital is a national and international referring center for management of vein of Galen malformations with a well-established multidisciplinary consultation pathway at the Maternal Fetal Care Center (MFCC). The trial is being conducted by a multidisciplinary group of specialists from the Boston Children’s Hospital Maternal Fetal Care Center, the Boston Children’s Cerebrovascular Surgery and Interventions Center, and Brigham and Women’s Hospital Maternal Fetal Medicine Group. This clinical group has significant expertise and has pioneered the development of fetal cardiac interventions for severe congenital heart anomalies, a different needle-based intervention. The fetal embolization intervention will be performed at Brigham and Women’s Hospital.
We are happy to provide more information about this trial upon request. If you have a patient who may be interested in this trial, please ask them to contact the Maternal Fetal Care Center at Boston Children’s Hospital, at 617-355-6512.
Recruitment Letter to Physicians
Funding: Departmental research funds