Petrous Apex MeningiomaAPEXNCT05639491
Petro-trigeminal Line and Petrous Apex Cephaloceles
An observational study of Petrous Apex Meningioma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Petrous Apex Meningioma
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 18 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Subject who expressed their opposition to participating in the study
- Kinetic Artifacts
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie 1 - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Official title: 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
- Conditions
- Petrous Apex Meningioma
- Keywords
- Petrous apex cephaloceles, Petrous apex, meckel's cave, cavum-trigeminale-cephaloceles, arachnoïd kyst, meningoceles, trigeminal nerves
- Medical subject headings
- Meningocele
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate a radiological landmark allowing MRI diagnosis cephaloceles of the petrous apex
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.
Measured: Files analysed retrospectively from from January 01, 2003 to September 31, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start18 Sep 2020
- Primary completion18 Oct 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Petrous Apex MeningiomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639491
- Sponsor's protocol ID
- 7960
- Acronym
- APEX
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Petro-trigeminal Line: a Simple Radiological Marker for the Diagnosis of Cephaloceles of the Petrous Apex on MRI
- ClinicalTrials.gov ID
- NCT05639491
- Acronym / sponsor ID
- APEX / 7960
- Conditions
- Petrous Apex Meningioma
- Keywords
- Petrous apex cephaloceles, Petrous apex, meckel's cave, cavum-trigeminale-cephaloceles, arachnoïd kyst, meningoceles, trigeminal nerves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Subject who expressed their opposition to participating in the study
- Kinetic Artifacts
- Subject under guardianship or curatorship
- Subject under safeguard of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Petrous Apex Meningioma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.