Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography (DRAPOPED)

July 2, 2019 updated by: Assistance Publique - Hôpitaux de Paris
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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Île De France
      • Le Kremlin-Bicêtre, Île De France, France, 94270
        • Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric population

Description

Inclusion Criteria:

  • Children aged under 18 years and under 80 kg;
  • Prior radiography perfomed within 6 months before the beginning of the study.

Exclusion Criteria:

- Refusal of parents to participate to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Catherine Adamsbaum, MD, PhD, Faculté de Médecine Paris Sud, Service de Radiologie Pédiatrique, C.H.U. Bicêtre
  • Study Director: Joëlle Feghali, MS, Service de Radiologie Pédiatrique, C.H.U. Bicêtre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19CAM-DRAPOPED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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