A Neonatal Bimodal MR-CT Head Template

NCT03674034 | Completed

• 1 other identifier: PI2017_843_0047
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Magnetic Resonance Imaging

Keywords

MRI images; CTscan

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

term

50 CTscan and MRI images of children aged at term

Other: CTscan and MRI images

one month

50 CTscan and MRI images of children aged one month

Other: CTscan and MRI images

two months

50 CTscan and MRI images of children aged two months

Other: CTscan and MRI images

Interventions

CTscan and MRI images OTHER

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

one month; term; two months

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• infants \> 2 months

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Officials

• Fabrice Wallois, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share