A Neonatal Bimodal MR-CT Head Template (Biomodal)

September 14, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CTscan images
Time Frame: 2 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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