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Crystalline Exposition During Pediatric Cranial CT Imaging

NCT ID: NCT03665181

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-02

Study Completion Date

2020-10-27

Brief Summary

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This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are associated with an eye's lens dose modulation

Detailed Description

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Eye's lens radiosensitivity represents an important subject of investigation in radiology. Indeed, eye's lens is recognised as one of the most radiosensitive organs in human body.\[1,2\] Radiation induced cataracts represent a determining effect of ionising radiations and has been widely studied. "International Commission for Radiological Protection" has evaluated cataract appearance threshold at 15 Gy in 1977 ",\[3\] then at 8 Gy \[4\] and 5 Gy in 2007.\[5\] Finally, in 2011 new studies gave rise to a new limit of appearance of 0.5 Gy. Eye's lens radiosensitivity seems to have been underestimated for several years and so there is a significant improvement to be made in radioprotection in order to protect to the best of the investigator's ability both patient and manipulator. This was also confirmed by the Directive EURATOM 2013/59 (which is in the process of being transposed in French legislation)\[6\] that reduces legal limit dose delivered to eye's lens from 150mSv to20mSv, for categories A workers.

This study is performed on 4 sequential groups, of ten patients, whereby one control group without ocular protection added. Other groups benefit either from a bismuth ocular protection, from a dose modulation applied to the eye's lens, or from both techniques associated. For each group, experiment is then focused on dose received by the eye's lens (measured using TLD detectors) as well as on Image quality obtained. Currently, there is no recommendation regarding lens protection for patient who benefit of a head tomodensitometry. Some practices are already used routinely but without a critical analysis of a comparison of their respective benefits.

Conditions

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Any Pathology Requiring a Cranial CT Imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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without modification of dose and without bismuth mask

The cranial CT imaging presrcibed in usual care will be performed without modification of dose and without bismuth mask

use or non-use of dose modulator and bismuth mask

Intervention Type OTHER

For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

with modification of dose and with bismuth mask

e cranial CT imaging presrcibed in usual care will be performed with modification of dose and with bismuth mask

use or non-use of dose modulator and bismuth mask

Intervention Type OTHER

For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

without modification of dose and with bismuth mask

e cranial CT imaging presrcibed in usual care will be performed without modification of dose and with bismuth mask

use or non-use of dose modulator and bismuth mask

Intervention Type OTHER

For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

with modification of dose and without bismuth mask

e cranial CT imaging presrcibed in usual care will be performed with modification of dose and without bismuth mask

use or non-use of dose modulator and bismuth mask

Intervention Type OTHER

For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

Interventions

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use or non-use of dose modulator and bismuth mask

For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children between 5 and 16 yrs old
* Indication of cerebral CT with or without contrast regardless to indication or exam specificity
* Patients beneficiary or affiliated to health system security
* Oral consent for data processing from the child and his/her representative of parental authority

Exclusion Criteria

* Children anxious or agitated
* Sedated patients or patients under general anaesthesia
* Impossibility to position the skull on the orbito-meatal plane (intubation for example)
* Patients under legal protection
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Commission of the French Radiology

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2018/11

Identifier Type: -

Identifier Source: org_study_id