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

Primary Purpose

Occlusion or Malformation of a Cerebral Vessel

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
protocol of optimization ALARA
protocol of optimization Philips
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occlusion or Malformation of a Cerebral Vessel

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondation ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

protocol of optimization ALARA

protocol of opimization Philips

Arm Description

protocol of optimization ALARA protocol of optimization of doses

protocol of optimization Philips usual protocol of optimization of doses

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2013
Last Updated
February 8, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02008305
Brief Title
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
Acronym
MINIRAD
Official Title
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occlusion or Malformation of a Cerebral Vessel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
protocol of optimization ALARA
Arm Type
Experimental
Arm Description
protocol of optimization ALARA protocol of optimization of doses
Arm Title
protocol of opimization Philips
Arm Type
Active Comparator
Arm Description
protocol of optimization Philips usual protocol of optimization of doses
Intervention Type
Device
Intervention Name(s)
protocol of optimization ALARA
Intervention Type
Device
Intervention Name(s)
protocol of optimization Philips
Primary Outcome Measure Information:
Title
Comparison of the average dose per child, according to the protocol
Time Frame
maximum one day per patient
Secondary Outcome Measure Information:
Title
number of X-rays photographs according to the protocol, quality of photographs according to the protocol,
Time Frame
maximum one day per patient
Other Pre-specified Outcome Measures:
Title
number of interrupted dosing
Time Frame
one day per patient

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Piotin
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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