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

NCT03302663 | Recruiting

• 1 other identifier: STH16555
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This project is split into 4 sections:

1. 1.Can improvements be made in the Magnetic resonance imaging sequences used to image the fetus in order to improve diagnostic accuracy?
2. 2.Does 3T improve the quality and diagnostic value of fetal MRI when compared to 1.5T
3. 3.Can fetal MRI be used to image the fetal heart?
4. 4.Can fetal MRI be used to image the fetal Bones?

Conditions

Fetal Conditions

Keywords

Fetal bone heart abnormality

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: MRI scan

Interventions

MRI scan DIAGNOSTIC_TEST

Addition of advanced imaging sequences for fetal MRI

Patient fetal bone abnormalities; Patients attending for a clinical scan; Patients who have requested a TOP; Patients with fetal heart abnormality

Eligibility Criteria

• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindication to MRI
• Severe claustrophobia

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, S10 2SF, United Kingdom

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Elspeth Whitby

  University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elspeth Whitby

CONTACT

01142262081; e.whitby@sheffield.ac.uk

Loretta Chantry-Groves

CONTACT

01142268515; loretta.chantry-groves@sth.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to appropriate arm depending on outcome of routine obstetric screening

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: October 5, 2017
• Study Start: August 1, 2013
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

GB (1)