Advanced Fetal Imaging - Phase II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advanced Fetal Imaging - Phase II

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Investigational MRI coil designed for pregnant women
* Procedure: MRI Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 minute research full MRI scan<br>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<br>* 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.<br>Procedure: MRI Scan<br>* 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.<br>|
| Experimental: 15 minute research add-on MRI scan<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal MRI, Pregnancy, Pregnant Women, MRI Coil, MRI Sequence Development/Testing, Abnormal Fetuses, Typically Developing Fetuses, Fetal MRI Technology Development