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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Pain; Acute Abdominal Pain
• Intervention / Treatment: Procedure: Additional MRI Examination

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.

• Study Type: Interventional
• Enrollment (Anticipated): 347
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingrid MILLET, MD, PhD; Phone Number: 0467338817; Email: i-millet@chu-montpellier.fr
• Study Contact Backup: Name: Patrice TAOUREL, MD, PhD; Phone Number: 0467338610; Email: p-taourel@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Departement of Medical Imaging
    • Contact: Ingrid MILLET, MD, PhD; Phone Number: 0467338817; Email: i-millet@chu-montpellier.fr
    • Contact: Patrice TAOUREL, MD, PhD; Phone Number: 0467338610; Email: p-taourel@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Direction Générale de l'Offre de Soins
• Investigators: Principal Investigator: Ingrid MILLET, MD, PhD, Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2017
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Pelvic pain; Diagnostic performance; Young women; Acute abdominal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Pelvic Pain; Abdomen, Acute
• Other Study ID Numbers: UF9803; 2017-A00725-48 (OTHER: Agence Nationale de Sécurité des Médicaments France)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No