Advanced Fetal Imaging - Phase II

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Device: Investigational MRI coil designed for pregnant women; Procedure: MRI Scan

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: P. Ellen Grant, MD; Phone Number: 857-218-5111; Email: ellen.grant@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: P. Ellen Grant, MD; Phone Number: 857-218-5111; Email: ellen.grant@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 60 minute research full MRI scan; 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.	Device: Investigational MRI coil designed for pregnant women; The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.; Procedure: MRI Scan; All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
Experimental: 15 minute research add-on MRI scan; 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.	Procedure: MRI Scan; All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research fetal MRI image quality compared to standard clinical fetal MRI image quality	Research fetal MRI image quality will be compared to the standard clinical fetal MRI image quality.	July 2016-December 2019, up to 41 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research fetal MRI image quality compared to standard obstetric ultrasound image quality	Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.	July 2016-December 2019, up to 41 months
Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound	Research fetal MRI physiology data (flow, perfusion, oxygen consumption) will be compared against standard obstetric physiological data obtained from ultrasound (e.g. Doppler measures).	July 2016-December 2019, up to 41 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Massachusetts General Hospital; Massachusetts Institute of Technology
• Investigators: Principal Investigator: P. Ellen Grant, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimated): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Pregnant Women; MRI Coil; Fetal MRI; MRI Sequence Development/Testing; Abnormal Fetuses; Typically Developing Fetuses; Fetal MRI Technology Development
• Other Study ID Numbers: R01EB017337 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO