Pediatric RadiologyDRAPOPEDNCT04007627
Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
An observational study of Pediatric Radiology, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Radiology
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to Aug 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population
Who may be able to join
- Children aged under 18 years and under 80 kg;
- Prior radiography perfomed within 6 months before the beginning of the study.
Who cannot join
- Refusal of parents to participate to the study.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP
Le Kremlin-Bicêtre, Île-de-France Region, 94270
About this study
To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).
Read the detailed description
The study will investigate the minimum dose required to obtain acceptable image quality for different pediatric localizations (abdomen, thorax, pelvis, spine) by using a simulation tool of different dose levels. Three different radiologists blinded to the simulated dose level will score the images independently by using a dedicated image quality scoring grid.
- Conditions
- Pediatric Radiology
- Keywords
- ALADA, IQ, Pediatric Radiology
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of image quality by radiologists blinded to the simulated dose level
Three different radiologists will score the images of localizations of abdomen, thorax, pelvis, spine independently by using a dedicated image quality scoring grid.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Jul 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric RadiologyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Adamsbaum, MD, PhD, Principal investigator, Faculté de Médecine Paris Sud, Service de Radiologie Pédiatrique, C.H.U. BicêtreJoëlle Feghali, MS, Study director, Service de Radiologie Pédiatrique, C.H.U. Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007627
- Sponsor's protocol ID
- 19CAM-DRAPOPED
- Acronym
- DRAPOPED
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 5 Jul 2019
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
- ClinicalTrials.gov ID
- NCT04007627
- Acronym / sponsor ID
- DRAPOPED / 19CAM-DRAPOPED
- Conditions
- Pediatric Radiology
- Keywords
- ALADA, IQ, Pediatric Radiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 5 Jul 2019 (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.
To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).
Detailed description
The study will investigate the minimum dose required to obtain acceptable image quality for different pediatric localizations (abdomen, thorax, pelvis, spine) by using a simulation tool of different dose levels. Three different radiologists blinded to the simulated dose level will score the images independently by using a dedicated image quality scoring grid.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population
Key inclusion criteria (2 listed)
- Children aged under 18 years and under 80 kg;
- Prior radiography perfomed within 6 months before the beginning of the study.
Key exclusion criteria (1 listed)
- Refusal of parents to participate to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assesment of image quality by radiologists blinded to the simulated dose level
Time frame: through study completion, an average of 6 months
Three different radiologists will score the images of localizations of abdomen, thorax, pelvis, spine independently by using a dedicated image quality scoring grid.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Catherine Adamsbaum, MD, PhD principal investigator
Faculté de Médecine Paris Sud, Service de Radiologie Pédiatrique, C.H.U. Bicêtre
Joëlle Feghali, MS study director
Service de Radiologie Pédiatrique, C.H.U. Bicêtre
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 Pediatric Radiology, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. 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?
Results are not available in the source record.
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?
Assesment of image quality by radiologists blinded to the simulated dose level (time frame: through study completion, an average of 6 months). 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 5 Jul 2019.