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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Direction Générale de l'Offre de Soins
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Acute Abdominal Pain Pelvic Pain Procedure: Additional MRI Examination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 347 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Diagnostic performances comparison between CT and MRI [ Time Frame: 3 months ]
    Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Inter-reader agreement for MRI and CT diagnoses [ Time Frame: 3 months ]
    Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
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
  • Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
  • Women unable to undergo informed consent (vulnerable or protected by law)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281031


Contacts
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Contact: Ingrid MILLET, MD, PhD 0467338817 i-millet@chu-montpellier.fr
Contact: Patrice TAOUREL, MD, PhD 0467338610 p-taourel@chu-montpellier.fr

Locations
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France
Departement of Medical Imaging Recruiting
Montpellier, France, 34295
Contact: Ingrid MILLET, MD, PhD    0467338817    i-millet@chu-montpellier.fr   
Contact: Patrice TAOUREL, MD, PhD    0467338610    p-taourel@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Direction Générale de l'Offre de Soins
Investigators
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Principal Investigator: Ingrid MILLET, MD, PhD Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03281031    
Other Study ID Numbers: UF9803
2017-A00725-48 ( Other Identifier: Agence Nationale de Sécurité des Médicaments France )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
MRI
Acute abdominal pain
Pelvic pain
Diagnostic performance
Young women
Additional relevant MeSH terms:
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Pelvic Pain
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive