PregnancyNCT02840019
Advanced Fetal Imaging - Phase II
A study testing Investigational MRI coil designed for pregnant women and MRI Scan in people with Pregnancy, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Investigational MRI coil designed for pregnant women and MRI Scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
P. Ellen Grant, MD, 857-218-5111, ellen.grant@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Investigational MRI coil designed for pregnant women, MRI Scan
- Keywords
- Fetal MRI, Pregnancy, Pregnant Women, MRI Coil, MRI Sequence Development/Testing, Abnormal Fetuses, Typically Developing Fetuses, Fetal MRI Technology Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational MRI coil designed for pregnant womenDevice
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 ScanProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 60 minute research full MRI scan | Experimental | 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. Receives: Device: Investigational MRI coil designed for pregnant women; Procedure: MRI Scan |
| 15 minute research add-on MRI scan | Experimental | 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. Receives: Procedure: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: July 2016-December 2019, up to 41 months
Secondary outcomes (2)
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.
Measured: July 2016-December 2019, up to 41 months
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).
Measured: July 2016-December 2019, up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Massachusetts General Hospital
- Responsible party
- Principal investigator, Ellen Grant, Boston Children's Hospital
- Investigators
- P. Ellen Grant, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840019
- Sponsor's protocol ID
- R01EB017337
- Status last verified
- Nov 2025
- First submitted
- 13 Jul 2016
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Fetal Imaging - Phase II
- ClinicalTrials.gov ID
- NCT02840019
- Acronym / sponsor ID
- R01EB017337
- Conditions
- Pregnancy
- Keywords
- Fetal MRI, Pregnancy, Pregnant Women, MRI Coil, MRI Sequence Development/Testing, Abnormal Fetuses, Typically Developing Fetuses, Fetal MRI Technology Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Massachusetts General Hospital
- Study start
- Jul 2016
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 minute research full MRI scan | Experimental | Device: Investigational MRI coil designed for pregnant women, Procedure: MRI ScanPregnant 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 | Experimental | Procedure: MRI ScanPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 60 Minute Full Research MRI Scan:
- 15 Minute Add-On Research Scan:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational MRI coil designed for pregnant womenThe 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. | Device | 60 minute research full MRI scan |
| MRI ScanAll participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes. | Procedure or surgery | 15 minute research add-on MRI scan, 60 minute research full MRI scan |
Primary outcome
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.
2 secondary outcomes
Research fetal MRI image quality compared to standard obstetric ultrasound image quality
Time frame: July 2016-December 2019, up to 41 months
Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound
Time frame: July 2016-December 2019, up to 41 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
P. Ellen Grant, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational MRI coil designed for pregnant women and MRI Scan in people with Pregnancy, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact P. Ellen Grant, MD (857-218-5111, ellen.grant@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.