Pregnancy RelatedFMASDNCT05253742
Fetal MRI Acquisition and Sequence Development
An observational study of Pregnancy Related, run by Massachusetts General Hospital.
Trial summary
Testing of new magnetic resonance imaging (MRI) pulse sequences (image acquisition software) for imaging the fetus to improve workflow and image quality in fetal imaging and diagnosis. The investigators would like to develop novel MRI approaches to enhance fetal imaging with MRI, in the presence of motion. Read more about this study
- Who is it for?
- Ages 13 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2023to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pregnant women presenting for imaging of the fetus
Eligibility will be determined prior to the scan session by a pre-screening interview conducted either via telephone or in person asking about MR contraindications.
Participants will be excluded from study entry or study completion when any of the following exclusion criteria are met at any time of screening or enrollment:
- Claustrophobia sufficient to interfere with MRI or render the subject unable to complete an MRI scan
- MRI contraindications (e.g., magnetically or mechanically activated implants)
- Weight greater than or equal to 300lbs (weight limit of the MRI table)
- Non-English speaking
- Neurological conditions (i.e. epilepsy, multiple sclerosis, neurodegenerative diseases, memory disorders, brain tumor)
- Past incidence of stroke or heart attack
- Severe hypertension, blood disorders, advanced diabetes mellitus, or advanced cardiovascular disease
- Hospitalization within 6 weeks prior to enrollment
- Significant acute and/or chronic medical conditions, current use of medications that indicate the existence of significant medical conditions, and other unspecified reasons that make the subject unsuitable for enrollment at the discretion at the PI and a consulting MD.
Pregnant mothers with the following features will be excluded.
- Mothers with contraindication to MRI (such as pacemaker, metal in body, exceeding scanner weight or bore diameter limits (550lbs, 70cm))
- Mothers with claustrophobia
- Mothers medically unstable for the MRI study
About this study
Testing of new magnetic resonance imaging (MRI) pulse sequences (image acquisition software) for imaging the fetus to improve workflow and image quality in fetal imaging and diagnosis. The investigators would like to develop novel MRI approaches to enhance fetal imaging with MRI, in the presence of motion. As part of technical development, the investigators plan to develop methods to improve structural T1 and T2 weighted images, MR angiography, diffusion and spectroscopy measurements of the fetus.
Read the detailed description
Fetal MRI has become a critical tool for both studying the early development of the human brain and resolving diagnostic ambiguities that may remain after routine ultrasound exams. Due to its excellent soft-tissue contrast and the absence of harmful ionizing radiation, MRI is preferable to computed tomography for neuroimaging. Unfortunately, fetal and maternal motion limit fetal MRI to rapid two-dimensional (2D) sequences with thick slices such as half-Fourier single-shot turbo spin echo (HASTE). Although these sequences decrease the impact of motion during the sub-second acquisition of individual slices, multiple slices are needed, and contiguous orthogonal scans are challenging as motion occurs between slices. Typically, >38% of acquisitions are discarded because of corrupted geometry and artifacts.
In this project the investigators will develop software that runs on the Siemens MRI scanner. This software will improve the workflow for fetal imaging i.e. for imaging the fetus in utero. Fetal imaging in its current form is inefficient due to the frequent motion of the fetus during the imaging procedure. In this project the investigators will develop automated methods for alignment and tracking of the fetus during imaging, to more efficiently image the fetus and to obtain better image quality in a shorter examination. The investigators are specifically interested in the fetal brain, but these methods may be generalized to all fetal organ systems. The investigators will install the software on the scanner and test these methods with volunteers.
- Conditions
- Pregnancy Related
- Being tested
- No intervention - the investigators are evaluating a new image acquisition method on an MRI scanner
- Keywords
- MRI, Fetus, Uterus, Placenta, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - the investigators are evaluating a new image acquisition method on an MRI scannerOther
The investigators will evaluate the performance of a modified MRI acquisition method against an existing method in fetal imaging in volunteers
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women presenting for MRI | Alternative motion-robust MR imaging sequences and procedures for automatic positioning while be tested during fetal brain imaging Receives: Other: No intervention - the investigators are evaluating a new image acquisition method on an MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image alignment in fetal MRI
Evaluation of image alignment with automatical positioning in MRI
Measured: Five year K99/R00 project
Tracking quality in fetal MRI
Evaluation of image quality with motion tracking in MRI
Measured: Five year K99/R00 project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start31 May 2023 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Why it stopped: The investigator decided to use existing data sets rather than to collect new data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre van der Kouwe, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253742
- Sponsor's protocol ID
- 2021P001433
- Acronym
- FMASD
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share data if requested as permitted by the Massachusetts General Brigham (MGB) Institutional Review Board (IRB).
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal MRI Acquisition and Sequence Development
- ClinicalTrials.gov ID
- NCT05253742
- Acronym / sponsor ID
- FMASD / 2021P001433
- Conditions
- Pregnancy Related
- Keywords
- MRI, Fetus, Uterus, Placenta, Brain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator decided to use existing data sets rather than to collect new data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 24 Feb 2022 (actual)
- 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.
Testing of new magnetic resonance imaging (MRI) pulse sequences (image acquisition software) for imaging the fetus to improve workflow and image quality in fetal imaging and diagnosis. The investigators would like to develop novel MRI approaches to enhance fetal imaging with MRI, in the presence of motion. As part of technical development, the investigators plan to develop methods to improve structural T1 and T2 weighted images, MR angiography, diffusion and spectroscopy measurements of the fetus.
Detailed description
Fetal MRI has become a critical tool for both studying the early development of the human brain and resolving diagnostic ambiguities that may remain after routine ultrasound exams. Due to its excellent soft-tissue contrast and the absence of harmful ionizing radiation, MRI is preferable to computed tomography for neuroimaging. Unfortunately, fetal and maternal motion limit fetal MRI to rapid two-dimensional (2D) sequences with thick slices such as half-Fourier single-shot turbo spin echo (HASTE). Although these sequences decrease the impact of motion during the sub-second acquisition of individual slices, multiple slices are needed, and contiguous orthogonal scans are challenging as motion occurs between slices. Typically, >38% of acquisitions are discarded because of corrupted geometry and artifacts.
In this project the investigators will develop software that runs on the Siemens MRI scanner. This software will improve the workflow for fetal imaging i.e. for imaging the fetus in utero. Fetal imaging in its current form is inefficient due to the frequent motion of the fetus during the imaging procedure. In this project the investigators will develop automated methods for alignment and tracking of the fetus during imaging, to more efficiently image the fetus and to obtain better image quality in a shorter examination. The investigators are specifically interested in the fetal brain, but these methods may be generalized to all fetal organ systems. The investigators will install the software on the scanner and test these methods with volunteers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women presenting for MRI | – | Other: No intervention - the investigators are evaluating a new image acquisition method on an MRI scannerAlternative motion-robust MR imaging sequences and procedures for automatic positioning while be tested during fetal brain imaging |
Who may qualify
- Ages
- 13 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pregnant women presenting for imaging of the fetus
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 |
|---|---|---|
| No intervention - the investigators are evaluating a new image acquisition method on an MRI scannerThe investigators will evaluate the performance of a modified MRI acquisition method against an existing method in fetal imaging in volunteers | Other | Pregnant women presenting for MRI |
Primary outcome
Image alignment in fetal MRI
Time frame: Five year K99/R00 project
Evaluation of image alignment with automatical positioning in MRI
Tracking quality in fetal MRI
Time frame: Five year K99/R00 project
Evaluation of image quality with motion tracking in MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. The investigators will share data if requested as permitted by the Massachusetts General Brigham (MGB) Institutional Review Board (IRB).
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image alignment in fetal MRI (time frame: Five year K99/R00 project). The study lists 2 primary outcomes in all. 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 11 Jun 2026.