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NCT Number: NCT06485323

MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.

It is possible to perform a pelvimetry by MRI as a substitute to pelvimetry by CT, hence sparing the patient from a dose of irradiation.

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universaires Siant Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

Frederic Lecouvet, MD-PhD

CONTACT

[email protected]

+3227642793

About this study

The Principal investigator want to evaluate new MRI sequences offering both an optimal contrast between mineral bone and soft tissues, and a shorter acquisition time. Indeed, the recent developments of specific MRI sequences to preferentially image the mineral bone (namely the ZTE and lavaflex 3D T1-weighted SPGR sequences) allow performing pelvimetry measurements on MR images offering an optimal "pseudo CT" contrast, with an MR acquisition time that is less than 10 minutes. Preliminary tests of these sequences have been carried out in our center in order to be able to implement these sequences on our clinical and research MRI machines. The study team wish to undertake a study to validate the use of this rapid and non-irradiating MRI approach, with the aim to replace a CT pelvimetry by a MRI pelvimetry demonstrated as being as reliable.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman 33 to 41 week
  • Woman who gave birth by cesarean section, for whom the obstetrician requests a pelvimetry CT for the next pregnancy
  • Pelvimetry planned by the obstetrical team outside of "emergency" pathway
  • Adhere to the study protocol after reading the patient information document have signed the informed consent form to participate in the study

Exclusion criteria

  • Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
  • Severe claustrophobia
  • uncomfortable back position

Treatment and study plan

MRI pelvimetry

Device

MRI of the pelvis

Primary outcomes

  1. Prove the non-inferiority of MRI compared to CT for pelvimetry.

    Time frame: 30 minutes (duration of the exam+ measurement)

    Measurement of pelvic bone diameters in pregnant women

Secondary outcomes

  1. Evaluate patient convenience for both examinations (CT and MRI)

    Time frame: immediately after both examinations

    questionnaire (scale from zero to ten, zero = more pleasant, ten=least pleasant)

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Lecouvet, MD, PhD

CONTACT

[email protected]

+3227642793

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

MRI Pseudo-CT Sequences for Obstetrical Pelvimetry

Acronym: Pelvi-MRI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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