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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03183427
Other study ID # 108/11-28/2017
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 8, 2017
Last updated June 10, 2017
Start date September 2017
Est. completion date September 2018

Study information

Verified date June 2017
Source Military University Hospital, Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
MR of the brain
MR of the brain without gadolinium, incl. T2-weighted image

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Military University Hospital, Prague

Outcome

Type Measure Description Time frame Safety issue
Primary size of corpus callosum size of corpus callosum in mm2 measured on the midsagittal T2-weighted MR scan time of the MR examination
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