Advanced Fetal Imaging - Phase II

Pregnancy Clinical Trial

Official title:

Advanced Fetal Imaging - Phase II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840019
• Other study ID #: R01EB017337
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Boston Children's Hospital
• Contact: P. Ellen Grant, MD
• Phone: 857-218-5111
• Email: ellen.grant[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Massachusetts General Hospital, Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Research fetal MRI image quality compared to standard obstetric ultrasound image quality	Research fetal MRI image quality will be compared against standard obstetric ultrasound image quality.	July 2016-December 2019, up to 41 months
Secondary	Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound	Research fetal MRI physiology data (flow, perfusion, oxygen consumption) will be compared against standard obstetric physiological data obtained from ultrasound (e.g. Doppler measures).	July 2016-December 2019, up to 41 months