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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Abdominal Pain
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 347
- Locations
- 1
- Primary Endpoint
- Diagnostic performances comparison between CT and MRI
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Diagnostic performances comparison between CT and MRI
Time Frame: 3 months
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
Secondary Outcomes
- 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 of unenhanced MRI sequences versus complete MRI examination(3 months)
- Inter-reader agreement for MRI and CT diagnoses(3 months)