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Advanced Fetal Imaging - Phase II

Advanced Fetal Imaging - Phase II

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02840019
Enrollment
300
Registered
2016-07-21
Start date
2016-07-31
Completion date
2028-06-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Fetal MRI, Pregnancy, Pregnant Women, MRI Coil, MRI Sequence Development/Testing, Abnormal Fetuses, Typically Developing Fetuses, Fetal MRI Technology Development

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.

Interventions

DEVICEInvestigational 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.

PROCEDUREMRI 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.

Sponsors

Massachusetts Institute of Technology
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Research fetal MRI image quality compared to standard clinical fetal MRI image qualityJuly 2016-December 2019, up to 41 monthsResearch fetal MRI image quality will be compared to the standard clinical fetal MRI image quality.

Secondary

MeasureTime frameDescription
Research fetal MRI image quality compared to standard obstetric ultrasound image qualityJuly 2016-December 2019, up to 41 monthsResearch 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 ultrasoundJuly 2016-December 2019, up to 41 monthsResearch fetal MRI physiology data (flow, perfusion, oxygen consumption) will be compared against standard obstetric physiological data obtained from ultrasound (e.g. Doppler measures).

Countries

United States

Contacts

Primary ContactP. Ellen Grant, MD
ellen.grant@childrens.harvard.edu857-218-5111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026