Advanced Fetal Imaging - Phase II

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT02840019
Status
Recruiting
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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 60 minute research full 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.
  • Experimental: 15 minute research add-on 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.

Primary Outcome Measure

Research fetal MRI image quality compared to standard clinical fetal MRI image quality [ Time Frame: July 2016-December 2019, up to 41 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
P. Ellen Grant, MD
[email protected]
857-218-5111

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By research site
Boston Children's Hospital· Boston, MA

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