Clinical trial NCT03281031: MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Abdominal Pain
Pelvic Pain
Keywords: MRI
Acute abdominal pain
Pelvic pain
Diagnostic performance
Young women
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2017-09-13
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Diagnostic performances comparison between CT and MRI
timeFrame: 3 months
Secondary outcomes:
measure: Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive
timeFrame: 3 months
measure: Diagnostic performances of unenhanced MRI sequences versus complete MRI examination
timeFrame: 3 months
measure: Inter-reader agreement for MRI and CT diagnoses
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement of Medical Imaging
Study officials:
affiliation: Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
name: Ingrid MILLET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: