NCT03665181

Crystalline Exposition During Pediatric Cranial CT Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Any Pathology Requiring a Cranial CT Imaging

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2018-09-11
• Last updated: 2020-10-29

Locations

1 site across 1 country: France