MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women

Not Applicable

• Conditions: Acute Abdominal Pain; Pelvic Pain
• Interventions: Procedure: Additional MRI Examination

• Registration Number: NCT03281031
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Objective :

To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.

Detailed Description

Methods :

Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the emergency Physician or gynaecologist after a non contributive ultrasonography will be included.

After obtaining informed consent, all patients will undergo standard CT followed by an additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.

The gold standard or reference diagnosis will be established in consensus by an expert panel at 3 months follow up using a standardized diagnosis form.

A retrospective reading will be performed independently for CT and MRI by radiologists blinded to the reference diagnosis, using the same standardized diagnosis form.

CT and MRI accuracies will be compared.

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Study Start: 2017-10-18
• Status Verified: 2021-12
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 347

Inclusion Criteria

• Women aged 18-40 years old
• Women referred to CT following a non contributive ultrasonography
• Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)
• Women with informed consent
• Women with affiliation to health insurance

Exclusion Criteria

• Women who underwent abdominopelvic surgery in the previous month
• Suspicion of vital emergency such as shock preventing any delayed management caused by MRI examination
• Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign bodies with risk of mobilization during MRI examination
• Women yet included in the study or included in another study
• Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
• Women unable to undergo informed consent (vulnerable or protected by law)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional MRI Examination	Additional MRI Examination	Single arm, all patient will undergo CT followed by additional MRI examination

Primary Outcome Measures

Name	Time	Method
Diagnostic performances comparison between CT and MRI	3 months	Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI

Secondary Outcome Measures

Name	Time	Method
Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive	3 months	Diagnostic performances (sensitivity, specificity and predictive values) of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive (strategy built retrospectively)
Diagnostic performances of unenhanced MRI sequences versus complete MRI examination	3 months	Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)
Inter-reader agreement for MRI and CT diagnoses	3 months	Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)

Trial Locations

Locations (1)

Departement of Medical Imaging; 🇫🇷 Montpellier, France