- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975712
Evaluation of the Pravalence of Rathke's Cleft Cyst of Children Under 15 Years (PREVA-KPR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rathke's cleft cysts (RCC) are benign cystic lesions in the sellar region and correspond to embryonic remnants of the Rathke's pouch. The prevalence of RCC in the literature is higher in adults than in children, but the data for children is limited and outdated. The hypothesis is that the frequency of RCC has been underestimated in children and that it actually decreases with age, especially in adults. The main objective of this descriptive study is to study the prevalence and signal of RCC in children under 15 years of age.
460 encephalic MRIs of children under 15 years of age comprising at least one sagittal sequence without T1-weighted injection and/or a T2 sagittal sequence adapted to the study of the pituitary gland, were analyzed retrospectively. Examination analyses was performed blindly by two radiologists for serous RCC, hypersignal on T2-weighted and isosignal T1-weighted sequences, and mucosal RCC, hyposignal on T2-weighted sequences and hyper or isosignal on T1-weighted sequences. The results were consensually read in case of disagreement on the presence or absence of an RCC.
Of the 460 patients included, the prevalence of RCC was 3% (14/460). 21% of the RCC cases (3/14) were serous and 79% (11/14) were mucosal. Of the 14 patients with RCC, a post-pituitary cyst was also found. The interobserver agreement was strong with a Cohen kappa coefficient of 0.85.
The prevalence of RCC in children under 15 years of age (3%) is higher than that described in the literature (1.2%) and is close to that of adults (3.9%). RCCs are thus intra-sellar lesions of relatively frequent discovery in children, i.e. to identify in order to not erroneously lead to a differential diagnosis including tumors which would lead to a different prognosis, management, and follow-up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Besançon, France
- Centre Hospitalier Universitaire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- children aged 15 or under at the time that an MRI was performed exploring the sellar region
- MRI with at least T1 spin echo (SE) sagittal slices with a slice thickness of 2.5 or 3 mm with inter-slice spacing of 0.3 mm and T2 SE with a slice thickness of 2 mm and inter-slice spacing of 0.2 mm.
Exclusion Criteria:
- Patients with incomplete MRI protocol
- Patients whose MRI images had artifacts (patient movement, presence of dental material)
- Patients with suspected pituitary pathology due to endocrine symptomatology (growth retardation, puberty delay, diabetes insipidus) that could be attributed to an intrasellar injury were also excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Presence or absence of a strictly intra-pituitary cystic lesion which localization and signal was compatible with an RCC, which type was defined according to its signal
Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account
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All MRI performed on a period of one year in children under 15 years will be taken into account
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum anteroposterior diameter (parallel to the bi-callous plane) of the cyst measured in sagittal section
Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account
|
All MRI performed on a period of one year in children under 15 years will be taken into account
|
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Cyst signal on T2-weighted spin echo sequence compared to cerebrospinal fluid (hypo / iso / hyper signal) and T1-weighted compared to cerebral white matter (hypo / iso / hyper signal)
Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account
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All MRI performed on a period of one year in children under 15 years will be taken into account
|
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Motive for which brain MRI was performed
Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account
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The motive can be:
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All MRI performed on a period of one year in children under 15 years will be taken into account
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Dimensions of pituitary
Time Frame: All MRI performed on a period of one year in children under 15 years will be taken into account
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All MRI performed on a period of one year in children under 15 years will be taken into account
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU de Besançon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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