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

Pelvic Pain Clinical Trial

— IRMADA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281031
• Other study ID #: UF9803
• Secondary ID: 2017-A00725-48
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: October 2022

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Ingrid MILLET, MD, PhD
• Phone: 0467338817
• Email: i-millet[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 347
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain
• Acute Abdominal Pain
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
France	Departement of Medical Imaging	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performances comparison between CT and MRI	Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI	3 months
Secondary	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
Secondary	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
Secondary	Inter-reader agreement for MRI and CT diagnoses	Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)	3 months