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

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

Sponsors

Lead Sponsor: University Hospital, Montpellier

Collaborator: Direction Générale de l'Offre de Soins

Source University Hospital, Montpellier
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.

Overall Status Unknown status
Start Date October 18, 2017
Completion Date March 2019
Primary Completion Date December 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Diagnostic performances comparison between CT and MRI 3 months
Secondary Outcome
Measure Time Frame
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
Enrollment 347
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Additional MRI Examination

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

Arm Group Label: Additional MRI Examination

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

- Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding

- Women unable to undergo informed consent (vulnerable or protected by law)

Gender: Female

Gender Based: Yes

Gender Description: Women

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ingrid MILLET, MD, PhD Principal Investigator Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
Overall Contact

Last Name: Ingrid MILLET, MD, PhD

Phone: 0467338817

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Departement of Medical Imaging Ingrid MILLET, MD, PhD 0467338817 [email protected]
Location Countries

France

Verification Date

November 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Additional MRI Examination

Type: Other

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

Acronym IRMADA
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov