MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women (IRMADA)
|ClinicalTrials.gov Identifier: NCT03281031|
Recruitment Status : Unknown
Verified November 2017 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : September 13, 2017
Last Update Posted : June 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Abdominal Pain Pelvic Pain||Procedure: Additional MRI Examination||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||347 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 18, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
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
- Diagnostic performances comparison between CT and MRI [ Time Frame: 3 months ]Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281031
|Contact: Ingrid MILLET, MD, PhDfirstname.lastname@example.org|
|Contact: Patrice TAOUREL, MD, PhDemail@example.com|
|Principal Investigator:||Ingrid MILLET, MD, PhD||Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital|