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

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2022

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.

Interventions

  • Procedure: Additional MRI Examination
    • MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results

Arms, Groups and Cohorts

  • Other: Additional MRI Examination
    • Single arm, all patient will undergo CT followed by additional MRI examination

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic performances comparison between CT and MRI
    • Time Frame: 3 months
    • Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI

Secondary Measures

  • 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)
  • 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)
  • Inter-reader agreement for MRI and CT diagnoses
    • Time Frame: 3 months
    • Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Women

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Collaborator
    • Direction Générale de l’Offre de Soins
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ingrid MILLET, MD, PhD, Principal Investigator, Departement of Medical Imaging – Montpellier University Hospital LAPEYRONIE Hospital
  • Overall Contact(s)
    • Ingrid MILLET, MD, PhD, 0467338817, i-millet@chu-montpellier.fr

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