Advanced Fetal Imaging - Phase II
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Jul 2016
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
December 8, 2025
November 1, 2025
10.9 years
July 13, 2016
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Research fetal MRI image quality compared to 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
July 2016-December 2019, up to 41 months
Study Arms (2)
60 minute research full MRI scan
EXPERIMENTALPregnant 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
EXPERIMENTALPregnant 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Minute Full Research MRI Scan:
- Gestational age between 18 and 40 weeks
- AND
- Pregnant women with a healthy pregnancy
- Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician
- Pregnant women with a concern for fetal/placental abnormalities NOT referred for a clinical fetal MRI by their obstetrician
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Massachusetts Institute of Technologycollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P. Ellen Grant, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 21, 2016
Study Start
July 1, 2016
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
December 8, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share