Advanced Fetal Imaging - Phase II

Boston Children's Hospital

Status: Enrolling

Conditions: Pregnancy

Treatments: Device: Investigational MRI coil designed for pregnant women; Procedure: MRI Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02840019

R01EB017337

Details and patient eligibility

About

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.

Full description

The main aim of this project is to evaluate and optimize the existing clinical magnetic resonance (MR) techniques for fetal imaging, and to also implement and test new MR technologies that would improve fetal imaging in general. This involves the development of new pulse sequences and image acquisition schemes that "freeze" fetal motion and hence provide improved image quality and robustness for both structural (T1- and T2- weighted, susceptibility and FLAIR imaging) and physiological imaging (diffusion, perfusion, spectroscopy, resting-state functional MRI, etc). The scope of this project also includes testing of newly developed radio frequency (RF) receive-only coil arrays that would inherently provide the means for faster imaging of the fetus, and thus complement the software developments.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 60 Minute Full Research MRI Scan:

  • 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

• 15 Minute Add-On Research Scan:

  • Gestational age between 18 and 40 weeks

    • AND

  • Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician

    • AND

  • The clinical fetal MRI will occur at Boston Children's Hospital

Exclusion criteria

• Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)
• Pregnant women who are claustrophobic
• Pregnant women who are medically unstable for an MRI

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

60 minute research full MRI scan

Experimental group

Description:

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.

Treatment:

Procedure: MRI Scan

Device: Investigational MRI coil designed for pregnant women

15 minute research add-on MRI scan

Experimental group

Description:

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.

Treatment:

Procedure: MRI Scan