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MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.

MRI Pseudo-CT Sequences for Obstetrical Pelvimetry

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06485323
Acronym
Pelvi-MRI
Enrollment
95
Registered
2024-07-03
Start date
2023-07-05
Completion date
2026-12-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Labor Complications

Keywords

technological progress

Brief summary

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.

Detailed description

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.

Interventions

DEVICEMRI pelvimetry

MRI of the pelvis

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Each patients will have a CT scan (classic follow-up) and an MRI (for the study)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prove the non-inferiority of MRI compared to CT for pelvimetry.30 minutes (duration of the exam+ measurement)Measurement of pelvic bone diameters in pregnant women

Secondary

MeasureTime frameDescription
Evaluate patient convenience for both examinations (CT and MRI)immediately after both examinationsquestionnaire (scale from zero to ten, zero = more pleasant, ten=least pleasant)

Countries

Belgium

Contacts

CONTACTFrédéric Lecouvet, MD, PhD
frederic.lecouvet@saintluc.uclouvain.be+3227642793
PRINCIPAL_INVESTIGATORFrédéric Lecouvet, MD, PhD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026