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Corpus Callosum Size in Patients With Pineal Cyst

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ClinicalTrials.gov Identifier: NCT03183427
Recruitment Status : Unknown
Verified June 2017 by Martin Majovsky, MD, Military University Hospital, Prague.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Majovsky, MD, Military University Hospital, Prague

Brief Summary:
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.

Condition or disease Intervention/treatment
Pineal Gland Disorder Corpus Callosum Atrophy Cerebral Palsy 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Corpus Callosum Size in Patients With Pineal Cyst
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
Group of patients with pineal cyst
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




Primary Outcome Measures :
  1. size of corpus callosum [ Time Frame: time of the MR examination ]
    size of corpus callosum in mm2 measured on the midsagittal T2-weighted MR scan



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.)
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Responsible Party: Martin Majovsky, MD, Senior physician, Military University Hospital, Prague
ClinicalTrials.gov Identifier: NCT03183427    
Other Study ID Numbers: 108/11-28/2017
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Atrophy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical