<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03302663</url>
  </required_header>
  <id_info>
    <org_study_id>STH16555</org_study_id>
    <nct_id>NCT03302663</nct_id>
  </id_info>
  <brief_title>The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice</brief_title>
  <official_title>The Value of Advanced Imaging Sequences for Fetal MRI in Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is split into 4 sections:&#xD;
&#xD;
        1. Can improvements be made in the Magnetic resonance imaging sequences used to image the&#xD;
           fetus in order to improve diagnostic accuracy?&#xD;
&#xD;
        2. Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T&#xD;
&#xD;
        3. Can fetal MRI be used to image the fetal heart?&#xD;
&#xD;
        4. Can fetal MRI be used to image the fetal Bones?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fetal MRI is rapidly expanding but the choice of sequences (the combination of variables that&#xD;
      produce the image and determine whether a specific tissue is highlighted at the expense of&#xD;
      other tissues e.g. some sequences highlight areas with a high water content, others highlight&#xD;
      tissues with a high fat content) is limited. Additional sequences have the potential to&#xD;
      improve the diagnostic accuracy but need to be developed and assessed before replacing the&#xD;
      current choices. In addition it is not possible to continue to add sequences to the list used&#xD;
      in clinical practice as each one takes time, which is limited in clinical practice. They may&#xD;
      also allow other body areas to be imaged successfully e.g. bones and heart that are not&#xD;
      currently imaged to a diagnostic level to be useful in clinical practice.&#xD;
&#xD;
      Until recently fetal MRI was restricted in the United Kingdom (UK) to magnet strengths of&#xD;
      1.5T although 3T was safely used in the rest of Europe. The restrictions have been lifted and&#xD;
      3T can now be used in the clinical setting for fetal MRI. The clinical value of this has not&#xD;
      been established (1) In this pilot study the investigators will aim to answer the above 4&#xD;
      questions.&#xD;
&#xD;
        1. Currently the T2 SSFSE is used as the main sequence and in some institutions&#xD;
           supplemented by T1 and diffusion-weighted imaging (DWI). The investigators wish to look&#xD;
           at other sequences that may be better than these for imaging certain areas of the baby.&#xD;
           The investigators have noted that the images used for imaging the placenta ( Balanced&#xD;
           gradient echo) show the edges of tissues well but do not give much internal detail.&#xD;
           However these images would be useful in cases of babies with cysts and may show the&#xD;
           extension of the cyst more clearly than the T2. However it is not possible to simply add&#xD;
           extra sequences to the scans as this takes extra time and is not appropriate in the&#xD;
           clinical setting. This pilot study will allow evaluation of the sequences and formal&#xD;
           comparison by a world-leading expert. This information will be used to guide local&#xD;
           clinical practice but also with further development in the future to develop national&#xD;
           guidelines.&#xD;
&#xD;
        2. 3T can now be used in the UK to image the fetus. Prior to imaging clinically at 3T it is&#xD;
           necessary to establish if there is any additional benefit. This pilot will allow us to&#xD;
           compare historical 1.5T images with 3T images to assess the potential benefit prior to a&#xD;
           larger study.&#xD;
&#xD;
        3. Currently the fetal heart appears as a black ill-defined mass on the images. The&#xD;
           investigators hope to use the balanced gradient echo sequence to image the heart.&#xD;
           Initially the investigators would like to be able to image 4 chambers reliably and then&#xD;
           to see if known pathology can be detected. If this is possible a larger study will be&#xD;
           designed for further development. The question the investigators are asking is a very&#xD;
           simple - can the investigators image the fetal heart? ' Yes/no and if so can the&#xD;
           investigators reliably see 4 chambers? Yes/no. This will not need quantitative analysis.&#xD;
&#xD;
        4. Similar to 3 as currently no definition in fetal bone is seen. The investigators wish to&#xD;
           apply sequences that reliably define the bone and then pilot these in cases with known&#xD;
           bone pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2013</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Establish the value of advanced imaging sequences for fetal MRI in clinical practice</measure>
    <time_frame>3 years</time_frame>
    <description>Part 1: improved imaging sequences that show areas better than the original sequences.&#xD;
Part 2: improved image quality when compared to similar (historical)cases done at 1.5T.&#xD;
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)&#xD;
Overall improved image detail and quality to aid diagnosis and management.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Fetal Conditions</condition>
  <arm_group>
    <arm_group_label>Patients attending for a clinical scan</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients attending for a clinical scan will be offered 2-4 extra sequences. The additional sequences and compare them to the currently established ones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients who have requested a TOP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with fetal heart abnormality</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient fetal bone abnormalities</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <description>Addition of advanced imaging sequences for fetal MRI</description>
    <arm_group_label>Patient fetal bone abnormalities</arm_group_label>
    <arm_group_label>Patients attending for a clinical scan</arm_group_label>
    <arm_group_label>Patients who have requested a TOP</arm_group_label>
    <arm_group_label>Patients with fetal heart abnormality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who are attending the fetal medicine clinic and are asked to consider&#xD;
             an MRI scan to provide information to help manage the current pregnancy.&#xD;
&#xD;
          -  Pregnant women requesting a termination of pregnancy who will allow us to do fetal MRI&#xD;
             at 3T prior to the termination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant females</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elspeth Whitby</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elspeth Whitby</last_name>
    <phone>01142262081</phone>
    <email>e.whitby@sheffield.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Loretta Chantry-Groves</last_name>
    <phone>01142268515</phone>
    <email>loretta.chantry-groves@sth.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sheffield Teaching Hospital NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elspeth Whitby</last_name>
      <phone>01142262081</phone>
      <email>e.whitby@sheffield.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Loretta Chantry-Groves</last_name>
      <phone>01142268515</phone>
      <email>loretta.chantry-groves@sth.nhs.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fetal bone heart abnormality</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03302663
org study id: STH16555
nct id: NCT03302663
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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?
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening
primary purpose: Diagnostic
masking: None (Open Label)
measure: Establish the value of advanced imaging sequences for fetal MRI in clinical practice
time frame: 3 years
description: 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.
arm group label: Patients attending for a clinical scan
arm group type: Other
description: Patients attending for a clinical scan will be offered 2-4 extra sequences. The additional sequences and compare them to the currently established ones.
arm group label: Patients who have requested a TOP
arm group type: Other
description: 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.
arm group label: Patients with fetal heart abnormality
arm group type: Other
description: 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.
arm group label: Patient fetal bone abnormalities
arm group type: Other
description: 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.
intervention type: Diagnostic Test
intervention name: MRI scan
description: Addition of advanced imaging sequences for fetal MRI
arm group label: Patient fetal bone abnormalities
arm group label: Patients attending for a clinical scan
arm group label: Patients who have requested a TOP
arm group label: Patients with fetal heart abnormality
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant females
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Elspeth Whitby
role: Principal Investigator
affiliation: University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust
last name: Elspeth Whitby
phone: 01142262081
email: e.whitby@sheffield.ac.uk
last name: Loretta Chantry-Groves
phone: 01142268515
email: loretta.chantry-groves@sth.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided