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The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice

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ClinicalTrials.gov Identifier: NCT03302663
Recruitment Status : Unknown
Verified October 2017 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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. Can fetal MRI be used to image the fetal Bones?

Condition or disease Intervention/treatment Phase
Fetal Conditions Diagnostic Test: MRI scan Not Applicable

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice
Actual Study Start Date : August 1, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients attending for a clinical scan
Patients attending for a clinical scan will be offered 2-4 extra sequences. The additional sequences and compare them to the currently established ones.
Diagnostic Test: MRI scan
Addition of advanced imaging sequences for fetal MRI

Patients who have requested a TOP
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.
Diagnostic Test: MRI scan
Addition of advanced imaging sequences for fetal MRI

Patients with fetal heart abnormality
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.
Diagnostic Test: MRI scan
Addition of advanced imaging sequences for fetal MRI

Patient fetal bone abnormalities
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.
Diagnostic Test: MRI scan
Addition of advanced imaging sequences for fetal MRI




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Contraindication to MRI
  • Severe claustrophobia

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): NCT03302663


Contacts
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Contact: Elspeth Whitby 01142262081 e.whitby@sheffield.ac.uk
Contact: Loretta Chantry-Groves 01142268515 loretta.chantry-groves@sth.nhs.uk

Locations
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United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SF
Contact: Elspeth Whitby    01142262081    e.whitby@sheffield.ac.uk   
Contact: Loretta Chantry-Groves    01142268515    loretta.chantry-groves@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
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Principal Investigator: Elspeth Whitby University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03302663     History of Changes
Other Study ID Numbers: STH16555
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Fetal bone heart abnormality