Fetal ConditionsNCT03302663
The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice
A study testing MRI scan in people with Fetal Conditions, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This project is split into 4 sections: 1. Can improvements be made in the Magnetic resonance imaging sequences used to image the fetus in order to improve diagnostic accuracy? 2. Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T 3. Can fetal MRI be used to image the fetal heart? 4. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Conditions
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2013to 31 Dec 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who are attending the fetal medicine clinic and are asked to consider an MRI scan to provide information to help manage the current pregnancy.
- Pregnant women requesting a termination of pregnancy who will allow us to do fetal MRI at 3T prior to the termination.
Who cannot join
- Contraindication to MRI
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, S10 2SF
Elspeth Whitby, 01142262081, e.whitby@sheffield.ac.uk
Loretta Chantry-Groves, 01142268515, loretta.chantry-groves@sth.nhs.uk
About this study
This project is split into 4 sections:
- Can improvements be made in the Magnetic resonance imaging sequences used to image the fetus in order to improve diagnostic accuracy?
- Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T
- Can fetal MRI be used to image the fetal heart?
- Can fetal MRI be used to image the fetal Bones?
Read the detailed description
Fetal MRI is rapidly expanding but the choice of sequences (the combination of variables that produce the image and determine whether a specific tissue is highlighted at the expense of other tissues e.g. some sequences highlight areas with a high water content, others highlight tissues with a high fat content) is limited. Additional sequences have the potential to improve the diagnostic accuracy but need to be developed and assessed before replacing the current choices. In addition it is not possible to continue to add sequences to the list used in clinical practice as each one takes time, which is limited in clinical practice. They may also allow other body areas to be imaged successfully e.g. bones and heart that are not currently imaged to a diagnostic level to be useful in clinical practice.
Until recently fetal MRI was restricted in the United Kingdom (UK) to magnet strengths of 1.5T although 3T was safely used in the rest of Europe. The restrictions have been lifted and 3T can now be used in the clinical setting for fetal MRI. The clinical value of this has not been established (1) In this pilot study the investigators will aim to answer the above 4 questions.
- Currently the T2 SSFSE is used as the main sequence and in some institutions supplemented by T1 and diffusion-weighted imaging (DWI). The investigators wish to look at other sequences that may be better than these for imaging certain areas of the baby. The investigators have noted that the images used for imaging the placenta ( Balanced gradient echo) show the edges of tissues well but do not give much internal detail. However these images would be useful in cases of babies with cysts and may show the extension of the cyst more clearly than the T2. However it is not possible to simply add extra sequences to the scans as this takes extra time and is not appropriate in the clinical setting. This pilot study will allow evaluation of the sequences and formal comparison by a world-leading expert. This information will be used to guide local clinical practice but also with further development in the future to develop national guidelines.
- 3T can now be used in the UK to image the fetus. Prior to imaging clinically at 3T it is necessary to establish if there is any additional benefit. This pilot will allow us to compare historical 1.5T images with 3T images to assess the potential benefit prior to a larger study.
- Currently the fetal heart appears as a black ill-defined mass on the images. The investigators hope to use the balanced gradient echo sequence to image the heart. Initially the investigators would like to be able to image 4 chambers reliably and then to see if known pathology can be detected. If this is possible a larger study will be designed for further development. The question the investigators are asking is a very simple - can the investigators image the fetal heart? ' Yes/no and if so can the investigators reliably see 4 chambers? Yes/no. This will not need quantitative analysis.
- Similar to 3 as currently no definition in fetal bone is seen. The investigators wish to apply sequences that reliably define the bone and then pilot these in cases with known bone pathology.
- Conditions
- Fetal Conditions
- Being tested
- MRI scan
- Keywords
- Fetal bone heart abnormality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
Addition of advanced imaging sequences for fetal MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients attending for a clinical scan | Other | Patients attending for a clinical scan will be offered 2-4 extra sequences. The additional sequences and compare them to the currently established ones. Receives: Diagnostic Test: MRI scan |
| Patients who have requested a TOP | Other | Women who have requested a termination of pregnancy (TOP) will be asked if they are willing to have a fetal MRI at 3T performed prior to the TOP. The images obtained will be compared to either images done clinically at 1.5T before the TOP request (if done and with the patients consent) or to images obtained at 1.5T of a similar gestation and pathology that the investigators obtained in a previous research study. Receives: Diagnostic Test: MRI scan |
| Patients with fetal heart abnormality | Other | The investigators plan to recruit patients with a fetus with heart abnormality on ultrasound and compare the MRI findings with the ultrasound findings and the clinical outcome. Receives: Diagnostic Test: MRI scan |
| Patient fetal bone abnormalities | Other | The investigators would like to ask women who have a fetus with bone abnormalities if they would be willing to have a fetal MRI. The findings will be compared to the ultrasound findings and the clinical or pathological findings after delivery. Receives: Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the value of advanced imaging sequences for fetal MRI in clinical practice
Part 1: improved imaging sequences that show areas better than the original sequences.
Part 2: improved image quality when compared to similar (historical)cases done at 1.5T.
Part 3 and 4: imaging of the fetal heart and bone that will be useful clinically (currently the images are not good enough to provide information for diagnosis and management)
Overall improved image detail and quality to aid diagnosis and management.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Aug 2013
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal ConditionsStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Elspeth Whitby, Principal investigator, University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302663
- Sponsor's protocol ID
- STH16555
- Status last verified
- May 2025
- First submitted
- 20 Jun 2017
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice
- ClinicalTrials.gov ID
- NCT03302663
- Acronym / sponsor ID
- STH16555
- Conditions
- Fetal Conditions
- Keywords
- Fetal bone heart abnormality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Oct 2017 (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.
This project is split into 4 sections:
- Can improvements be made in the Magnetic resonance imaging sequences used to image the fetus in order to improve diagnostic accuracy?
- Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T
- Can fetal MRI be used to image the fetal heart?
- Can fetal MRI be used to image the fetal Bones?
Detailed description
Fetal MRI is rapidly expanding but the choice of sequences (the combination of variables that produce the image and determine whether a specific tissue is highlighted at the expense of other tissues e.g. some sequences highlight areas with a high water content, others highlight tissues with a high fat content) is limited. Additional sequences have the potential to improve the diagnostic accuracy but need to be developed and assessed before replacing the current choices. In addition it is not possible to continue to add sequences to the list used in clinical practice as each one takes time, which is limited in clinical practice. They may also allow other body areas to be imaged successfully e.g. bones and heart that are not currently imaged to a diagnostic level to be useful in clinical practice.
Until recently fetal MRI was restricted in the United Kingdom (UK) to magnet strengths of 1.5T although 3T was safely used in the rest of Europe. The restrictions have been lifted and 3T can now be used in the clinical setting for fetal MRI. The clinical value of this has not been established (1) In this pilot study the investigators will aim to answer the above 4 questions.
- Currently the T2 SSFSE is used as the main sequence and in some institutions supplemented by T1 and diffusion-weighted imaging (DWI). The investigators wish to look at other sequences that may be better than these for imaging certain areas of the baby. The investigators have noted that the images used for imaging the placenta ( Balanced gradient echo) show the edges of tissues well but do not give much internal detail. However these images would be useful in cases of babies with cysts and may show the extension of the cyst more clearly than the T2. However it is not possible to simply add extra sequences to the scans as this takes extra time and is not appropriate in the clinical setting. This pilot study will allow evaluation of the sequences and formal comparison by a world-leading expert. This information will be used to guide local clinical practice but also with further development in the future to develop national guidelines.
- 3T can now be used in the UK to image the fetus. Prior to imaging clinically at 3T it is necessary to establish if there is any additional benefit. This pilot will allow us to compare historical 1.5T images with 3T images to assess the potential benefit prior to a larger study.
- Currently the fetal heart appears as a black ill-defined mass on the images. The investigators hope to use the balanced gradient echo sequence to image the heart. Initially the investigators would like to be able to image 4 chambers reliably and then to see if known pathology can be detected. If this is possible a larger study will be designed for further development. The question the investigators are asking is a very simple - can the investigators image the fetal heart? ' Yes/no and if so can the investigators reliably see 4 chambers? Yes/no. This will not need quantitative analysis.
- Similar to 3 as currently no definition in fetal bone is seen. The investigators wish to apply sequences that reliably define the bone and then pilot these in cases with known bone pathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening
| Arm | Type | Receives |
|---|---|---|
| Patients attending for a clinical scan | Other | Diagnostic Test: MRI scanPatients attending for a clinical scan will be offered 2-4 extra sequences. The additional sequences and compare them to the currently established ones. |
| Patients who have requested a TOP | Other | Diagnostic Test: MRI scanWomen who have requested a termination of pregnancy (TOP) will be asked if they are willing to have a fetal MRI at 3T performed prior to the TOP. The images obtained will be compared to either images done clinically at 1.5T before the TOP request (if done and with the patients consent) or to images obtained at 1.5T of a similar gestation and pathology that the investigators obtained in a previous research study. |
| Patients with fetal heart abnormality | Other | Diagnostic Test: MRI scanThe investigators plan to recruit patients with a fetus with heart abnormality on ultrasound and compare the MRI findings with the ultrasound findings and the clinical outcome. |
| Patient fetal bone abnormalities | Other | Diagnostic Test: MRI scanThe investigators would like to ask women who have a fetus with bone abnormalities if they would be willing to have a fetal MRI. The findings will be compared to the ultrasound findings and the clinical or pathological findings after delivery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women who are attending the fetal medicine clinic and are asked to consider an MRI scan to provide information to help manage the current pregnancy.
- Pregnant women requesting a termination of pregnancy who will allow us to do fetal MRI at 3T prior to the termination.
Key exclusion criteria (2 listed)
- Contraindication to MRI
- Severe claustrophobia
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 |
|---|---|---|
| MRI scanAddition of advanced imaging sequences for fetal MRI | Diagnostic test | Patient fetal bone abnormalities, Patients attending for a clinical scan, Patients who have requested a TOP, Patients with fetal heart abnormality |
Primary outcome
Establish the value of advanced imaging sequences for fetal MRI in clinical practice
Time frame: 3 years
Part 1: improved imaging sequences that show areas better than the original sequences. Part 2: improved image quality when compared to similar (historical)cases done at 1.5T. Part 3 and 4: imaging of the fetal heart and bone that will be useful clinically (currently the images are not good enough to provide information for diagnosis and management) Overall improved image detail and quality to aid diagnosis and management.
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 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Elspeth Whitby principal investigator
University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Fetal Conditions, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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 4 Jun 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 Kingdom. 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 Elspeth Whitby (01142262081, e.whitby@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the value of advanced imaging sequences for fetal MRI in clinical practice (time frame: 3 years). 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 4 Jun 2025.