Petro-trigeminal Line and Petrous Apex Cephaloceles (APEX)

November 7, 2023 updated by: University Hospital, Strasbourg, France

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Radiologie 1 - CHU de Strasbourg - France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Major subjects (≥18 years old) who underwent an MRI with high resolution 3D T2 sequence between 01/01/2003 and 09/31/2020:

  • consulting for ENT pathology such as vertigo
  • or presenting the radiological criteria in MRI of a cephalocele of the petrous

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Files analysed retrospectively from from January 01, 2003 to September 31, 2020 will be examined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

October 18, 2020

Study Completion (Actual)

November 18, 2020

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

November 25, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7960

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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