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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A00725-48 | Other Identifier | Agence Nationale de Sécurité des Médicaments France |
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Logistical constraints at the centers
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional MRI Examination | Other | Single arm, all patient will undergo CT followed by additional MRI examination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional MRI Examination | Procedure | MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performances comparison between CT and MRI | Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid MILLET, MD, PhD | Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Medical Imaging | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40307528 | Result | Charret O, Fournier L, Poncelet E, Duraes M, Bobbia X, Bazot M, Beranger S, Chaumoitre K, Arcis E, Rousset P, Coutureau J, Fillias Q, Delebecq J, Pages-Bouic E, Molinari N, Nogue E, Taourel P, Millet I. MRI as an alternative to CT after inconclusive ultrasound in subacute/acute abdominal pain in young women: a prospective multicenter noninferiority study. Eur Radiol. 2025 Nov;35(11):6642-6654. doi: 10.1007/s00330-025-11629-7. Epub 2025 Apr 30. |
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| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
| Inter-reader agreement for MRI and CT diagnoses | Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading) | 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |