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

University Hospital Center (CHU)

Status: Unknown

Conditions: Acute Abdominal Pain; Pelvic Pain

Treatments: Procedure: Additional MRI Examination

Study type: Interventional

Funder types: Other

Identifiers

NCT03281031

UF9803

2017-A00725-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 347 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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347 participants in 1 patient group

Additional MRI Examination

Other group

Description:

Single arm, all patient will undergo CT followed by additional MRI examination

Treatment:

Procedure: Additional MRI Examination