MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women (IRMADA)
Primary Purpose
Acute Abdominal Pain, Pelvic Pain
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional MRI Examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Abdominal Pain focused on measuring MRI, Acute abdominal pain, Pelvic pain, Diagnostic performance, Young women
Eligibility Criteria
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)
Sites / Locations
- Departement of Medical ImagingRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Additional MRI Examination
Arm Description
Single arm, all patient will undergo CT followed by additional MRI examination
Outcomes
Primary Outcome Measures
Diagnostic performances comparison between CT and MRI
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
Secondary Outcome Measures
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)
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)
Inter-reader agreement for MRI and CT diagnoses
Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)
Full Information
NCT ID
NCT03281031
First Posted
July 27, 2017
Last Updated
June 3, 2022
Sponsor
University Hospital, Montpellier
Collaborators
Direction Générale de l'Offre de Soins
1. Study Identification
Unique Protocol Identification Number
NCT03281031
Brief Title
MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Direction Générale de l'Offre de Soins
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Abdominal Pain, Pelvic Pain
Keywords
MRI, Acute abdominal pain, Pelvic pain, Diagnostic performance, Young women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
347 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Additional MRI Examination
Arm Type
Other
Arm Description
Single arm, all patient will undergo CT followed by additional MRI examination
Intervention Type
Procedure
Intervention Name(s)
Additional MRI Examination
Intervention Description
MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results
Primary Outcome Measure Information:
Title
Diagnostic performances comparison between CT and MRI
Description
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive
Description
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)
Time Frame
3 months
Title
Diagnostic performances of unenhanced MRI sequences versus complete MRI examination
Description
Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)
Time Frame
3 months
Title
Inter-reader agreement for MRI and CT diagnoses
Description
Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid MILLET, MD, PhD
Phone
0467338817
Email
i-millet@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice TAOUREL, MD, PhD
Phone
0467338610
Email
p-taourel@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid MILLET, MD, PhD
Organizational Affiliation
Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Medical Imaging
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid MILLET, MD, PhD
Phone
0467338817
Email
i-millet@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Patrice TAOUREL, MD, PhD
Phone
0467338610
Email
p-taourel@chu-montpellier.fr
12. IPD Sharing Statement
Learn more about this trial
MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women
We'll reach out to this number within 24 hrs