Advanced Fetal Imaging - Phase II

Not Applicable

Recruiting

• Conditions: Pregnancy
• Interventions: Device: Investigational MRI coil designed for pregnant women; Procedure: MRI Scan

• Registration Number: NCT02840019
• Lead Sponsor: Boston Children's Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 minute research full MRI scan	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.
15 minute research add-on MRI scan	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.
60 minute research full MRI scan	Investigational MRI coil designed for pregnant women	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.

Primary Outcome Measures

Name	Time	Method
Research fetal MRI image quality compared to standard clinical fetal MRI image quality	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 Outcome Measures

Name	Time	Method
Research fetal MRI image quality compared to standard obstetric ultrasound image quality	July 2016-December 2019, up to 41 months	Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.
Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound	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).

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States