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Recruiting NCT02840019

Advanced Fetal Imaging - Phase II

No phase Interventional Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigational MRI coil designed for pregnant women, MRI Scan.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Research fetal MRI image quality compared to standard clinical fetal MRI image quality [Time frame: July 2016-December 2019, up to 41 months]
Secondary outcome measures (2)
  • Research fetal MRI image quality compared to standard obstetric ultrasound image quality [Time frame: July 2016-December 2019, up to 41 months]
  • Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound [Time frame: July 2016-December 2019, up to 41 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Identifiers

NCT: NCT02840019 · R01EB017337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗