APEX: Petro-trigeminal Line and Petrous Apex Cephaloceles

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05639491
Collaborator
(none)
209
1
27.4
7.6

Study Details

Study Description

Brief Summary

cephaloceles are rare lesions of the petrous apex, inconsistently listed as meningoceles or arachnoid cysts. They're consistent with a herniation posterolateral of the Meckel cavum within the petrous apex. These lesions may be the cause of a symptomatology varied, or be discovered by chance in subjects who have not been asymptomatic. Currently, there is no evidence in the literature a simple, fast and reproducible radiological marker that allows for the diagnosis of cephaloceles of the petrous apex, in particular the small ones. The purpose of this study is to validate a radiological benchmark simple and reproducible, the trigeminal petrol line, in order to improve the diagnosis of petrous apex cephaloceles

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    209 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Petro-trigeminal Line: a Simple Radiological Marker for the Diagnosis of Cephaloceles of the Petrous Apex on MRI
    Actual Study Start Date :
    Sep 18, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Validate a radiological landmark allowing MRI diagnosis cephaloceles of the petrous apex [Files analysed retrospectively from from January 01, 2003 to September 31, 2020 will be examined]

      This mark corresponds to the projection of a line drawn on an axial section, in the plane of the posterior roots of the trigeminal nerves, between the anterior and external edges of the petrous apex along the petro-trigeminal angle on each side.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • Major subjects (≥18 years old)

    • patients who underwent an MRI with high resolution 3D T2 sequence between 01/01/2003 and 09/31/2020:

    • 200 patients consulting for ENT pathology such as vertigo

    • 9 patients presenting the radiological criteria in MRI of a cephalocele of the petrous apex according to the current data of the literature on a T2 3D HR sequence

      • Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.
    Exclusion criteria:
    • Subject who expressed their opposition to participating in the study

    • Kinetic Artifacts

    • Subject under guardianship or curatorship

    • Subject under safeguard of justice

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Radiologie 1 - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05639491
    Other Study ID Numbers:
    • 7960
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 6, 2022