Any Pathology Requiring a Cranial CT ImagingECTOPICNCT03665181
Crystalline Exposition During Pediatric Cranial CT Imaging
An observational study of Any Pathology Requiring a Cranial CT Imaging, run by University Hospital, Bordeaux at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Any Pathology Requiring a Cranial CT Imaging
- What is being tested?
- use or non-use of dose modulator and bismuth mask
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2018to 27 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- use or non-use of dose modulator and bismuth mask
- Keywords
- Radioprotection, dosimetry, tomodensitometry, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use or non-use of dose modulator and bismuth maskOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: use or non-use of dose modulator and 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 Receives: Other: use or non-use of dose modulator and 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 Receives: Other: use or non-use of dose modulator and 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 Receives: Other: use or non-use of dose modulator and bismuth mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (3)
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
Measured: 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
Measured: Baseline
Image quality
Quantitative analysis of the image quality obtained with both systems after CT acquisition. Quality will be assessed by radiologist's categorization
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start2 Oct 2018
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Pathology Requiring a Cranial CT ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Commission of the French Radiology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665181
- Sponsor's protocol ID
- CHUBX 2018/11
- Acronym
- ECTOPIC
- Status last verified
- Oct 2020
- First submitted
- 7 Sep 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystalline Exposition During Pediatric Cranial CT Imaging
- ClinicalTrials.gov ID
- NCT03665181
- Acronym / sponsor ID
- ECTOPIC / CHUBX 2018/11
- Keywords
- Radioprotection, dosimetry, tomodensitometry, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Commission of the French Radiology
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| without modification of dose and without bismuth mask | – | Other: use or non-use of dose modulator and bismuth maskThe cranial CT imaging presrcibed in usual care will be performed without modification of dose and without bismuth mask |
| with modification of dose and with bismuth mask | – | Other: use or non-use of dose modulator and bismuth maske cranial CT imaging presrcibed in usual care will be performed with modification of dose and with bismuth mask |
| without modification of dose and with bismuth mask | – | Other: use or non-use of dose modulator and bismuth maske cranial CT imaging presrcibed in usual care will be performed without modification of dose and with bismuth mask |
| with modification of dose and without bismuth mask | – | Other: use or non-use of dose modulator and bismuth maske cranial CT imaging presrcibed in usual care will be performed with modification of dose and without bismuth mask |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use or non-use of dose modulator and bismuth maskFor 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 | Other | with modification of dose and with bismuth mask, with modification of dose and without bismuth mask, without modification of dose and with bismuth mask, without modification of dose and without bismuth mask |
Primary outcome
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
3 secondary outcomes
Efficiency of a bismuth based ocular protection
Time frame: Baseline
Efficiency of eye's lens dose modification
Time frame: Baseline
Image quality
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Pathology Requiring a Cranial CT Imaging, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of a bismuth based ocular protection associated with eye's lens dose modulation technique (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020; AzTrials last refreshed its copy on 30 Oct 2026.