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

University Hospital, Montpellier347 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

347

Conditions

Acute Abdominal Pain Pelvic Pain

Interventions

Additional MRI ExaminationPROCEDURE

MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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)

Locations (1)

Departement of Medical Imaging

Montpellier, France

RECRUITING

Outcomes

Primary Outcomes

Diagnostic performances comparison between CT and MRI

Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI

Time frame: 3 months

Secondary Outcomes

Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive

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)

Time frame: 3 months

Diagnostic performances of unenhanced MRI sequences versus complete MRI examination

Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)

Time frame: 3 months

Inter-reader agreement for MRI and CT diagnoses

Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)

Time frame: 3 months

Central Contacts

Ingrid MILLET, MD, PhD

CONTACT

0467338817 i-millet@chu-montpellier.fr

Patrice TAOUREL, MD, PhD

CONTACT

0467338610 p-taourel@chu-montpellier.fr

Data from ClinicalTrials.gov

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