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Completed

NCT Number: NCT03665181

Crystalline Exposition During Pediatric Cranial CT Imaging

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

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

use or non-use of dose modulator and bismuth mask

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

Primary outcomes

  1. Efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique

    Time frame: Baseline

    quantification of the efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique during cranial CT of children. This will be measured by the average dose difference relative to the number of helices, kV and mAs delivered between groups 1 and 2

Secondary outcomes

  1. Efficiency of a bismuth based ocular protection

    Time frame: Baseline

    Quantification of the efficiency of a bismuth based ocular protection during CT acquisition. This will be measured by the average dose difference relative to the number of helices, kV and mAs delivered between groups 1 and 3

  2. Efficiency of eye's lens dose modification

    Time frame: Baseline

    Quantification of the efficiency of eye's lens dose modification technique during CT acquisition. This will be measured by the average dose difference relative to the number of helices, kV and mAs delivered between groups 1 and 4

  3. Image quality

    Time frame: Baseline

    Quantitative analysis of the image quality obtained with both systems after CT acquisition. Quality will be assessed by radiologist's categorization

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Commission of the French Radiology

Registry information

Acronym: ECTOPIC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.