Crystalline Exposition During Pediatric Cranial CT Imaging (ECTOPIC)

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

Study Overview

• Status: Completed
• Conditions: Any Pathology Requiring a Cranial CT Imaging
• Intervention / Treatment: Other: use or non-use of dose modulator and bismuth mask

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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Chu Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population include all children for who a cranial CT imaging will be required within usual care in the radiology ward of Bordeaux University Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
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	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
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Image quality	Quantitative analysis of the image quality obtained with both systems after CT acquisition. Quality will be assessed by radiologist's categorization	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Commission of the French Radiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ACTUAL): October 27, 2020
• Study Completion (ACTUAL): October 27, 2020

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: pediatrics; dosimetry; Radioprotection; tomodensitometry
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Bismuth
• Other Study ID Numbers: CHUBX 2018/11

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