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NCT Number: NCT02840019

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

P. Ellen Grant, MD

CONTACT

[email protected]

857-218-5111

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational MRI coil designed for pregnant women

Device

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

Procedure

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 outcomes

  1. Research fetal MRI image quality compared to standard clinical fetal MRI image quality

    Time frame: July 2016-December 2019, up to 41 months

    Research fetal MRI image quality will be compared to the standard clinical fetal MRI image quality.

Secondary outcomes

  1. Research fetal MRI image quality compared to standard obstetric ultrasound image quality

    Time frame: July 2016-December 2019, up to 41 months

    Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.

  2. Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound

    Time frame: July 2016-December 2019, up to 41 months

    Research fetal MRI physiology data (flow, perfusion, oxygen consumption) will be compared against standard obstetric physiological data obtained from ultrasound (e.g. Doppler measures).

Study contacts

Contact information is provided by the study sponsor or research team.

P. Ellen Grant, MD

CONTACT

[email protected]

857-218-5111

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Massachusetts General Hospital
  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2016
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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