Clinical Trials Directory

Trials / Unknown

UnknownNCT03281031

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
347 (estimated)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAdditional MRI ExaminationMRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results

Timeline

Start date
2017-10-18
Primary completion
2022-10-01
Completion
2022-10-01
First posted
2017-09-13
Last updated
2022-06-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03281031. Inclusion in this directory is not an endorsement.