Clinical trial NCT02840019: Advanced Fetal Imaging - Phase II
Official title: Advanced Fetal Imaging - Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Fetal MRI
Pregnancy
Pregnant Women
MRI Coil
MRI Sequence Development/Testing
Abnormal Fetuses
Typically Developing Fetuses
Fetal MRI Technology Development
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: Massachusetts General Hospital
First posted: 2016-07-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: Research fetal MRI image quality compared to standard clinical fetal MRI image quality
timeFrame: July 2016-December 2019, up to 41 months
Secondary outcomes:
measure: Research fetal MRI image quality compared to standard obstetric ultrasound image quality
timeFrame: July 2016-December 2019, up to 41 months
measure: Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound
timeFrame: July 2016-December 2019, up to 41 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: P. Ellen Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: