Crystalline Exposition During Pediatric Cranial CT Imaging

Any Pathology Requiring a Cranial CT Imaging Clinical Trial

— ECTOPIC  

Official title:

Crystalline Exposition During Pediatric Cranial CT Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665181
• Other study ID #: CHUBX 2018/11
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: October 27, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Any Pathology Requiring a Cranial CT Imaging

Intervention

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

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Commission of the French Radiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique	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	Baseline
Secondary	Efficiency of a bismuth based ocular protection	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	Baseline
Secondary	Efficiency of eye's lens dose modification	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	Baseline
Secondary	Image quality	Quantitative analysis of the image quality obtained with both systems after CT acquisition. Quality will be assessed by radiologist's categorization	Baseline