We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advanced Fetal Imaging - Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840019
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : August 11, 2022
Sponsor:
Collaborators:
Massachusetts Institute of Technology
Massachusetts General Hospital
Information provided by (Responsible Party):
Ellen Grant, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Investigational MRI coil designed for pregnant women Procedure: MRI Scan Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advanced Fetal Imaging - Phase II
Study Start Date : July 2016
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Device: Investigational 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.

Procedure: MRI 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.

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.

Procedure: MRI 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.




Primary Outcome Measures :
  1. Research fetal MRI image quality compared to standard clinical fetal MRI image quality [ Time Frame: 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 :
  1. Research fetal MRI image quality compared to standard obstetric ultrasound image quality [ Time Frame: July 2016-December 2019, up to 41 months ]
    Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.

  2. Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840019


Contacts
Layout table for location contacts
Contact: P. Ellen Grant, MD 857-218-5111 ellen.grant@childrens.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: P. Ellen Grant, MD    857-218-5111    ellen.grant@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
Massachusetts Institute of Technology
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: P. Ellen Grant, MD Boston Children's Hospital
Layout table for additonal information
Responsible Party: Ellen Grant, Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02840019    
Other Study ID Numbers: R01EB017337 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ellen Grant, Boston Children's Hospital:
Fetal MRI
Pregnancy
Pregnant Women
MRI Coil
MRI Sequence Development/Testing
Abnormal Fetuses
Typically Developing Fetuses
Fetal MRI Technology Development