Corpus Callosum Size in Patients With Pineal Cyst

This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Pineal Gland Disorder; Corpus Callosum Atrophy
• Intervention / Treatment: Diagnostic test: MR of the brain

Detailed Description

A pineal cyst (PC) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. Etiopathogenesis of PC is unknown, several hypotheses have been proposed. One of the hypothesis consider perinatal hypoxia as a causative factor for a development of PC in later life. Ozmen et al. showed significantly higher prevalence of PC in patients with cerebral palsy (p<0.001). Bregant et al. studied presence of PC in patients that suffered from a mild to moderate perinatal hypoxia. Prevalence of PC reached 36 % in these patients and presence of PC was associated with a atrophy of the corpus callosum (p<0.005). The atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period.

In the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance T2-weighted scan in the group of patients with PC and in the control group without PC. The goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and PC. Such finding would support abovementioned theory of etiopathogenesis of PC.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• study group: consecutive patients with pineal cyst that were examined in our institution between 2000-2017
• control group: matched healthy subjects without pineal cyst

Description

Inclusion Criteria:

• 3T MR examination of the brain including T2 sagittal scans

Exclusion Criteria:

• other intracranial pathology discovered on the MR
• other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group of patients with pineal cyst	Diagnostic test: MR of the brain; MR of the brain without gadolinium, incl. T2-weighted image
Control group; Group of subjects without pineal cyst	Diagnostic test: MR of the brain; MR of the brain without gadolinium, incl. T2-weighted image

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
size of corpus callosum	size of corpus callosum in mm2 measured on the midsagittal T2-weighted MR scan	time of the MR examination

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 10, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 108/11-28/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No