A Neonatal Bimodal MR-CT Head Template (Biomodal)

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Other: CTscan and MRI images

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Population 150 CTscan and MRI images of children aged between 0 and 2 months with no structural abnormalities when interpreted by the radiologist.

An age group of 50 images of children at term, 50 images of children at one month, 50 images of children at two months for each category (MRI and CTscan) Since these images will be averaged by age group, it is not necessary to obtain the two images for each child.

Description

Inclusion Criteria:

• children aged between 0 and 2 months new born at term
• with no structural abnormalities

Exclusion Criteria:

• infants > 2 months

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
term; 50 CTscan and MRI images of children aged at term	Other: CTscan and MRI images; CTscan and MRI images segmented according to procedures previously developed by GRAMFC
one month; 50 CTscan and MRI images of children aged one month	Other: CTscan and MRI images; CTscan and MRI images segmented according to procedures previously developed by GRAMFC
two months; 50 CTscan and MRI images of children aged two months	Other: CTscan and MRI images; CTscan and MRI images segmented according to procedures previously developed by GRAMFC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: MRI images; CTscan
• Other Study ID Numbers: PI2017_843_0047

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