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TerminatedNCT02008305MINIRADUpdated Feb 9, 2017

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

An interventional study of protocol of optimization ALARA and protocol of optimization Philips in Occlusion or Malformation of a Cerebral Vessel, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2017-02-09.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
Up to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Occlusion or Malformation of a Cerebral Vessel
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 2 is below the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion criteria

Exclusion Criteria:

  • opposition ot the parent(s) to the participation of their child in the trial and/or no social security.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    protocol of optimization ALARA

    protocol of optimization ALARA protocol of optimization of doses

    Device: protocol of optimization ALARA

  • Active comparator
    protocol of opimization Philips

    protocol of optimization Philips usual protocol of optimization of doses

    Device: protocol of optimization Philips

Interventions

  • Deviceprotocol of optimization ALARA
  • Deviceprotocol of optimization Philips
06

What researchers measure

Primary outcomes

  1. Comparison of the average dose per child, according to the protocol

    Time frame: maximum one day per patient

Secondary outcomes

  1. number of X-rays photographs according to the protocol, quality of photographs according to the protocol,

    Time frame: maximum one day per patient

Other outcomes

  1. number of interrupted dosing

    Time frame: one day per patient

07

Study locations

1 site
  • Fondation ophtalmique Adolphe de Rothschild
    Paris, 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02008305
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Dec 11, 2013
Start date
Nov 2013
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Feb 9, 2017

Study contacts

Michel Piotin
principal investigator · Fondation Ophtalmologique Adolphe de Rothschild

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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