CholesteatomaCHOLEMRINCT03915392
Diffusion Weighted MRI Accuracy in Cholesteatoma Localization
An observational study of Cholesteatoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholesteatoma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent cholesteatoma surgery between January 1, 2010 and December 31, 2017
Who may be able to join
- Age: from 1 month and up
- Sex: man / woman
- Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:
- Code of the Common Classification of Medical Acts (CCAM)
- Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002)
- Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006)
Show all 22Show fewer
- Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005)
- Tympanoplasty in closed technique with posterior tympanotomy (CBMD001)
- Secondary tympanoplasty in closed technique (CBMD002)
- Diagnostic code of the International Classification of Diseases (ICD10)
- Cholesteatoma of the middle ear (H71)
- Diagnosis of macroscopic and / or pathological cholesteatoma.
- Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).
- Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.
- Cholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects.
- Criteria of non-inclusion
- Refusal of the patient to participate in the study
- Absence of data concerning the diagnosis and / or localization of cholesteatoma on the operative record
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy (woman of childbearing age)
- Breastfeeding
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Orl Et de Chirurgie Cervico-Faciale
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr
Antoine MERANGER, MD, 33 3 88 12 76 49, antoine.meranger@chru-strasbourg.fr
About this study
Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management
- Conditions
- Cholesteatoma
- Keywords
- Diffusion weighted MRI, Cholesteatoma, Localization
- Medical subject headings
- Cholesteatoma
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI imaging study to locate cholesteatoma.
Measured: The period from January 1st, 2010 to Dcember 31, 2017 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 posted16 Apr 2019
- Study start1 Jul 2018
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesteatomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CHARPIOT, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915392
- Sponsor's protocol ID
- 7122
- Acronym
- CHOLEMRI
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 16 Apr 2019
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted MRI Accuracy in Cholesteatoma Localization
- ClinicalTrials.gov ID
- NCT03915392
- Acronym / sponsor ID
- CHOLEMRI / 7122
- Conditions
- Cholesteatoma
- Keywords
- Diffusion weighted MRI, Cholesteatoma, Localization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 16 Apr 2019 (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.
Magnetic resonance imaging of the middle ear has an increasing place in the therapeutic strategy in otology and especially for cholesteatoma. It is currently performed for complicated cholesteatomas and as part of the follow-up of operated patients to detect a recurrence or a cholesteatoma residue (alternative of choice to "second look" surgery). Some people take CT and MRI fusion to improve the localization of cholesteatoma. Many studies have investigated the diagnostic capabilities of MRI but very few have demonstrate their reliability in location diagnosis. The aim of the study was to propose a topographic reading method of the MRI of the middle ear and to evaluate the performances in the localization of the cholesteatoma in order to adapt the surgical management
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cholesteatoma surgery between January 1, 2010 and December 31, 2017
Key inclusion criteria (22 listed)
- Age: from 1 month and up
- Sex: man / woman
- Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:
- Diagnosis of macroscopic and / or pathological cholesteatoma.
- Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).
Key exclusion criteria (0 listed)
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
MRI imaging study to locate cholesteatoma.
Time frame: The period from January 1st, 2010 to Dcember 31, 2017 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Anne CHARPIOT, MD, PhD study director
University Hospital, Strasbourg, France
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 Cholesteatoma, 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 22 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne CHARPIOT, MD, PhD (33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI imaging study to locate cholesteatoma. (time frame: The period from January 1st, 2010 to Dcember 31, 2017 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 16 Apr 2019.