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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study

Conditions
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Acute Abdominal Pain, Pelvic Pain

Intervention / Treatment
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* Procedure: Additional MRI Examination


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Additional MRI Examination<br>Single arm, all patient will undergo CT followed by additional MRI examination | Procedure: Additional MRI Examination<br>* MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performances comparison between CT and MRI | Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 3 months | 
| Inter-reader agreement for MRI and CT diagnoses | Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Pelvic pain, Acute abdominal pain, Diagnostic performance, Young women