Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

Pediatric Radiology Clinical Trial

— DRAPOPED  

Official title:

Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04007627
• Other study ID #: 19CAM-DRAPOPED
• Status: Enrolling by invitation
• Start date: July 15, 2019
• Est. completion date: August 2019

Study information

• Verified date: June 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Radiology

Locations

Country	Name	City	State
France	Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP	Le Kremlin-Bicêtre	Île De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 6 months