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OpenTrials
Completed

NCT Number: NCT05639491

Petro-trigeminal Line and Petrous Apex Cephaloceles

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Radiologie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validate a radiological landmark allowing MRI diagnosis cephaloceles of the petrous apex

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

The Petro-trigeminal Line: a Simple Radiological Marker for the Diagnosis of Cephaloceles of the Petrous Apex on MRI

Acronym: APEX

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2022
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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