Evaluation of the Pravalence of Rathke's Cleft Cyst of Children Under 15 Years

NCT03975712 | Completed

• 1 other identifier: CHU de Besançon
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study was to evaluate the pravalence of Rathke's Cleft Cyst of children under 15 years of age and demonstrate that their prevalence is higher than for patients over 15 years of age, due to their embryonic origin. It is also aimed to describe their aspect on MRI and evaluate the interobserver agreement in the detection of Rathke's Cleft Cyst.

Conditions

Rathke's Cleft Cyst

Outcome Measures

Primary Outcomes (1)

• 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

  All MRI performed on a period of one year in children under 15 years will be taken into account

Secondary Outcomes (4)

• Maximum anteroposterior diameter (parallel to the bi-callous plane) of the cyst measured in sagittal section

  All MRI performed on a period of one year in children under 15 years will be taken into account

• 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)

  All MRI performed on a period of one year in children under 15 years will be taken into account

• Motive for which brain MRI was performed

  All MRI performed on a period of one year in children under 15 years will be taken into account

• Dimensions of pituitary

  All MRI performed on a period of one year in children under 15 years will be taken into account

Interventions

Not applicable, no intervention OTHER

Not applicable, no intervention

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

children aged 15 or under at the time that an MRI was performed exploring the sellar region

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire

Besançon, France

Location

MeSH Terms

Conditions

Central Nervous System Cysts

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 5, 2019
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)