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

June 11, 2026 updated by: University Hospital, Montpellier

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

Terminated

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 (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34295
        • Departement of Medical Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Additional MRI Examination
Single arm, all patient will undergo CT followed by 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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ingrid MILLET, MD, PhD, Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 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 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • UF9803
  • 2017-A00725-48 (Other Identifier: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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