ClinicalTrials.gov
ClinicalTrials.gov Menu

Crystalline Exposition During Pediatric Cranial CT Imaging (ECTOPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03665181
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
Commission of the French Radiology
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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

Condition or disease Intervention/treatment
Any Pathology Requiring a Cranial CT Imaging 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
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Crystalline Exposition During Pediatric Cranial CT Imaging
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665181


Contacts
Contact: Tom SKLADANEK +335 56 79 56 79 ext 14233 tom.skladanek@chu-bordeaux.fr

Locations
France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Tom Skladanek       tom.skladanek@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Commission of the French Radiology

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03665181     History of Changes
Other Study ID Numbers: CHUBX 2018/11
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Radioprotection
dosimetry
tomodensitometry
pediatrics

Additional relevant MeSH terms:
Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents