Recruiting

Advanced Fetal Imaging

Sponsor:

Boston Children's Hospital

Code:

NCT02840019

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Investigational MRI coil designed for pregnant women

MRI Scan

Study Details

Brief summary:

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.

Conditions

Pregnancy

Study ID

NCT02840019

Start date

Jul, 2016

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Research fetal MRI image quality compared to standard clinical fetal MRI image quality [ Time Frame: July 2016-December 2019, up to 41 months ]

Central Contacts and Locations

Central contacts

P. Ellen Grant, MD

857-218-5111ellen.grant@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

P. Ellen Grant, MD

857-218-5111ellen.grant@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 8, 2025

Last verified

Nov, 2025

Keywords

  • Fetal MRI
  • Pregnancy
  • Pregnant Women
  • MRI Coil
  • MRI Sequence Development/Testing
  • Abnormal Fetuses
  • Typically Developing Fetuses
  • Fetal MRI Technology Development

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-08.