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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03674034
Other study ID # PI2017_843_0047
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date January 1, 2017

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective study based on the images contained in the database of the University Hospital of Amiens. There is no further examination. Electroencephalography (EEG) and Near-Infrared Spectroscopy (NIRS). These sources are widely used to specify the source of certain evoked potentials or to better define the sources of epileptic graphoelements, especially in the pre-surgical assessment of refractory epilepsies.

It is therefore important that these regions are more widely available in the constitution of the world, and that they are suitable for use in the design of new technologies. Although MRI is the gold standard for soft tissue segmentation, it is not suitable for bone extraction; especially in the newborn or the bone is very thin. On the other hand, CTscan is an excellent method for extracting bone. The contrast between bone and soft tissue is excellent. In this case, with the CTscan, the fontanelles are identified as discontinuities between the images of the temporal scales.


Description:

Magnetic resonance imaging (MRI) and brain scan (CT Scan) are the two main modalities of structural brain imaging that are widely used in routine practice. The extraction of bone from MRI and CTscan images is an important step in the segmentation of the different tissues of the subjects' heads. It is indeed necessary to know precisely the electrical characteristics (conductivities) and optical (absorption, diffraction) of tissues (skin, bone, LCS, gray matter and white matter), or by electric currents or by photons. One of the major problems is the one that is not very poorly visualized in MRIs in CTscan, the bone is well individualized and that inversely the various brain structures are difficult to extract. This justifies the fact of performing a coregistration of images obtained in MRI and CTscan.

The skull of the newborn is an inhomogeneous structure. The fontanelles are invisible in MRI and identifiable in CTscan.

Electroencephalography (EEG) and Near-Infrared Spectroscopy (NIRS). These sources are widely used to specify the source of certain evoked potentials or to better define the sources of epileptic graphoelements, especially in the pre-surgical assessment of refractory epilepsies.

It is therefore important that these regions are more widely available in the constitution of the world, and that they are suitable for use in the design of new technologies.

Although MRI is the gold standard for soft tissue segmentation, it is not suitable for bone extraction; especially in the newborn or the bone is very thin. On the other hand, CTscan is an excellent method for extracting bone. The contrast between bone and soft tissue is excellent. In this case, with the CTscan, the fontanelles are identified as discontinuities between the images of the temporal scales.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 1, 2017
Est. primary completion date January 1, 2016
Accepts healthy volunteers No
Gender Male
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

- children aged between 0 and 2 months new born at term

- with no structural abnormalities

Exclusion Criteria:

- infants > 2 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CTscan and MRI images
CTscan and MRI images segmented according to procedures previously developed by GRAMFC

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type Measure Description Time frame Safety issue
Primary CTscan images The objective of this study is to evaluate a model-based approach for extracting fontanel from CTscan images. Then, recalibrate these CT scan images in a unique repository with MRI images to obtain a composite image of different brain tissues such as brain, LCS and skin (MRI) and bone and fontanelle (CTscan). 2 months
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