Advanced Fetal MRI for Pregnancy Imaging
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Implanted metal, Claustrophobia, Medically unstable, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women and testing recently developed MRI image acquisition techniques. The investigators aim to more reliably obtain higher quality fetal MRI images when compared to current clinical fetal MRI.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Investigational MRI coil designed for pregnant women?
Research shows that advanced MRI techniques provide excellent images of both the mother and fetus without needing sedation, helping to identify various conditions like fetal brain development issues and maternal complications. This suggests that the investigational MRI coil could improve imaging quality and diagnostic capabilities during pregnancy.
12345Is MRI safe for pregnant women?
MRI is generally considered safe during pregnancy, but there are some concerns about using contrast agents and sedation, which should be avoided if possible. The safety of MRI during the first trimester or with gadolinium contrast is not well known.
46789How is the investigational MRI coil for pregnant women different from other treatments?
The investigational MRI coil for pregnant women is unique because it is specifically designed to improve the quality of fetal imaging during pregnancy, potentially using higher magnetic field strengths like 3.0 T, which can provide more detailed images compared to the more common 1.5 T MRI used in standard practice.
12101112Eligibility Criteria
This trial is for pregnant women with either a healthy pregnancy or concerns for fetal abnormalities, between 18 and 40 weeks of gestation. They must be referred for an MRI by their obstetrician if there are concerns. Women can't join if they're claustrophobic, have metal implants, non-removable piercings, pacemakers, or are medically unstable.Inclusion Criteria
should eat a healthy diet
I am between 18 and 40 weeks pregnant.
Gestational age between 18 and 40 weeks AND Pregnant women with a healthy pregnancy OR Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician OR Pregnant women with a concern for fetal/placental abnormalities NOT referred for a clinical fetal MRI by their obstetrician
+1 more
Exclusion Criteria
Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)
Pregnant women who are medically unstable for an MRI
You are pregnant and have a fear of enclosed spaces.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
MRI Scan
Participants undergo a 60 minute research full MRI scan using investigational MRI coils and sequences
1 day
1 visit (in-person)
Add-on MRI Scan
Participants with specific concerns undergo a 15 minute research add-on MRI scan
1 day
1 visit (in-person)
Follow-up
Participants are monitored for image quality and physiological data comparison
up to 41 months
Participant Groups
The study tests a new MRI coil designed specifically for pregnant women alongside advanced image acquisition techniques to improve the quality of fetal MRI images compared to current methods.
2Treatment groups
Experimental Treatment
Group I: 60 minute research full MRI scanExperimental Treatment2 Interventions
Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor.
The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.
Group II: 15 minute research add-on MRI scanExperimental Treatment1 Intervention
Pregnant women with a concern for fetal/placental abnormalities with a clinical fetal MRI at Boston Children's Hospital are eligible for the 15 minute research add-on MRI scan.
The research MRI sequences will also be tested during the add-on research MRI scan.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
Massachusetts Institute of TechnologyCollaborator
Massachusetts General HospitalCollaborator
References
Obstetric MR imaging. [2007]The surge in the development of fast magnetic resonance (MR) techniques has revolutionized our ability to image the pregnant patient and the fetus. Fast MR imaging techniques provide excellent resolution for imaging the maternal and fetal anatomies without the need for sedation. This article addresses the use of fast MR imaging techniques in the evaluation of the pregnant patient for adnexal masses, pelvimetry, hydroureteronephrosis of pregnancy, and placenta accreta. In addition, fetal anomalies for which MR imaging has proved useful, such as ventriculomegaly, arachnoid cysts, and abdominal masses, are described.
Fetal magnetic resonance imaging at 3.0 T. [2022]Magnetic resonance imaging (MRI) has been used to image the in utero fetus for the past 3 decades. Although not as commonplace as other patient-oriented MRI, it is a growing field and demonstrating a role in the clinical care of the fetus. Indeed, the body of literature involving fetal MRI exceeds 3000 published articles. Indeed, there is interest in accessing even the healthy fetus with MRI to further understand the development of humans during the fetal stage. On the horizon is fetal imaging using 3.0-T clinical systems. Although a clear path is not necessarily determined, experiments, theoretical calculations, advances in pulse sequence design, new hardware, and experience from imaging at 1.5 T help define the path.
Quantitative magnetic resonance imaging of the fetal brain in utero: Methods and applications. [2021]Application of modern magnetic resonance imaging (MRI) techniques to the live fetus in utero is a relatively recent endeavor. The relative advantages and disadvantages of clinical MRI relative to the widely used and accepted ultrasonographic approach are the subject of a continuing debate; however the focus of this review is on the even younger field of quantitative MRI as applied to non-invasive studies of fetal brain development. The techniques covered under this header include structural MRI when followed by quantitative (e.g., volumetric) analysis, as well as quantitative analyses of diffusion weighted imaging, diffusion tensor imaging, magnetic resonance spectroscopy and functional MRI. The majority of the published work reviewed here reflects information gathered from normal fetuses scanned during the 3(rd) trimester, with relatively smaller number of studies of pathological samples including common congenital pathologies such as ventriculomegaly and viral infection.
Safety of Magnetic Resonance Imaging in Pregnancy. [2023]Magnetic resonance imaging is being increasingly used to diagnose and follow up a variety of medical conditions in pregnancy, both for maternal and fetal indications. However, limited data regarding its safe use in pregnancy may be a source of anxiety and avoidance for both patients and their healthcare providers. In this review, we critically discuss the main safety concerns of Magnetic Resonance Imaging (MRI) in pregnancy including energy deposition, acoustic noise, and use of contrast agents, supported by data from animal and human studies. Use of maternal sedatives and concerns related to occupational exposure in pregnant personnel are also addressed. Exposure to gadolinium-based contrast agents and sedation for MRI during pregnancy should be avoided whenever feasible.
Diagnostic Imaging of Pregnant Women - The Role of Magnetic Resonance Imaging. [2020]Presentation of magnetic resonance imaging (MRI) findings in pregnant women in the Department of Diagnostic Imaging, Institute of Mother and Child, Warsaw, Poland.
Magnetic Resonance Safety: Pregnancy and Lactation. [2021]MRI is a powerful diagnostic tool with excellent soft tissue contrast that uses nonionizing radiation. These advantages make MRI an appealing modality for imaging the pregnant patient; however, specific risks inherent to the magnetic resonance environment must be considered. MRI may be performed without and/or with intravenous contrast, which adds further fetal considerations. The risks of MRI with and without intravenous contrast are reviewed as they pertain to the pregnant or lactating patient and to the fetus and nursing infant. Relevant issues for gadolinium-based contrast agents and ultrasmall paramagnetic iron oxide particles are reviewed.
Utilization of 3-T fetal magnetic resonance imaging in clinical practice: a single-institution experience. [2021]As the safety and efficacy of fetal magnetic resonance imaging (MRI) at 3 tesla (T) continues to evolve, understanding its potential benefits and limitations is becoming increasingly important.
Fetal MRI, lower acceptance by women in research vs. clinical setting. [2019]To determine acceptance of pregnant women to undergo fetal magnetic resonance imaging (MRI) examination in research and clinical setting.
Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes. [2022]Fetal safety of magnetic resonance imaging (MRI) during the first trimester of pregnancy or with gadolinium enhancement at any time of pregnancy is unknown.
Fetal MRI at 3T-ready for routine use? [2022]Fetal MR now plays an important role in the clinical work-up of pregnant females. It is performed mainly at 1.5 T. However, the desire to obtain a more precise fetal depiction or the fact that some institutions have access only to a 3.0 T scanner has resulted in a growing interest in performing fetal MR at 3.0 T. The aim of this article was to provide a reference for the use of 3.0 T MRI as a prenatal diagnostic method.
Fetal magnetic resonance imaging: a review. [2007]To describe advances in magnetic resonance technology and the current indications and advantages of magnetic resonance imaging that have led to increased utilization in fetal medicine.
Fetal magnetic resonance imaging. [2007]Fast magnetic resonance imaging (MRI) has revolutionized our ability to image the fetus. Using fast scanning techniques, individual images are obtained in 300-400 ms, allowing for imaging of the fetus without sedation. MRI is most useful for evaluation of the anomalous fetal central nervous system, for further characterization of complex anomalies not fully elucidated by ultrasound and for evaluation of patients desiring fetal surgery. This review describes the history of fetal MRI, discusses current applications and mentions developments on the horizon.