NCT03281031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

December 1, 2021

Enrollment Period

5 years

First QC Date

July 27, 2017

Last Update Submit

June 3, 2022

Conditions

Acute Abdominal PainPelvic Pain

Keywords

MRIAcute abdominal painPelvic painDiagnostic performanceYoung women

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performances comparison between CT and MRI

    Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI

    3 months

Secondary Outcomes (3)

  • Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive

    3 months

  • Diagnostic performances of unenhanced MRI sequences versus complete MRI examination

    3 months

  • Inter-reader agreement for MRI and CT diagnoses

    3 months

Study Arms (1)

Additional MRI Examination

OTHER

Single arm, all patient will undergo CT followed by additional MRI examination

Procedure: Additional MRI Examination

Interventions

Additional MRI ExaminationPROCEDURE

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

Additional MRI Examination

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Medical Imaging

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Abdomen, AcutePelvic Pain

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Ingrid MILLET, MD, PhD

    Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid MILLET, MD, PhD

CONTACT

0467338817i-millet@chu-montpellier.fr

Patrice TAOUREL, MD, PhD

CONTACT

0467338610p-taourel@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

September 13, 2017

Study Start

October 18, 2017

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

June 6, 2022

Record last verified: 2021-12

Locations

FR(1)