Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Occlusion or Malformation of a Cerebral Vessel Clinical Trial

— MINIRAD  

Official title:

Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02008305
• Other study ID #: SC/DM_MPN_2012-4
• Status: Terminated
• Phase: N/A
• First received: December 3, 2013
• Last updated: February 8, 2017
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion Criteria:

• opposition ot the parent(s) to the participation of their child in the trial and/or no social security.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Occlusion or Malformation of a Cerebral Vessel

Intervention

Device:
• protocol of optimization ALARA

• protocol of optimization Philips

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of interrupted dosing		one day per patient
Primary	Comparison of the average dose per child, according to the protocol		maximum one day per patient
Secondary	number of X-rays photographs according to the protocol, quality of photographs according to the protocol,		maximum one day per patient