Occlusion or Malformation of a Cerebral VesselMINIRADNCT02008305
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
A study testing protocol of optimization ALARA and protocol of optimization Philips in people with Occlusion or Malformation of a Cerebral Vessel, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Occlusion or Malformation of a Cerebral Vessel
- What is being tested?
- protocol of optimization ALARA and protocol of optimization Philips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology
Who cannot join
- opposition ot the parent(s) to the participation of their child in the trial and/or no social security.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Being tested
- protocol of optimization ALARA, protocol of optimization Philips
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocol of optimization ALARADevice
protocol of optimization PhilipsDevice
| Study group | Role | What they receive |
|---|---|---|
| protocol of optimization ALARA | Experimental | protocol of optimization ALARA protocol of optimization of doses Receives: Device: protocol of optimization ALARA |
| protocol of opimization Philips | Active comparator | protocol of optimization Philips usual protocol of optimization of doses Receives: Device: protocol of optimization Philips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the average dose per child, according to the protocol
Measured: maximum one day per patient
Secondary outcomes (1)
number of X-rays photographs according to the protocol, quality of photographs according to the protocol,
Measured: maximum one day per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occlusion or Malformation of a Cerebral VesselStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michel Piotin, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008305
- Sponsor's protocol ID
- SC/DM_MPN_2012-4
- Acronym
- MINIRAD
- Status last verified
- Feb 2017
- First submitted
- 3 Dec 2013
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
- ClinicalTrials.gov ID
- NCT02008305
- Acronym / sponsor ID
- MINIRAD / SC/DM_MPN_2012-4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protocol of optimization ALARA | Experimental | Device: protocol of optimization ALARAprotocol of optimization ALARA protocol of optimization of doses |
| protocol of opimization Philips | Active comparator | Device: protocol of optimization Philipsprotocol of optimization Philips usual protocol of optimization of doses |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology
Key exclusion criteria (1 listed)
- opposition ot the parent(s) to the participation of their child in the trial and/or no social security.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocol of optimization ALARA | Device | protocol of optimization ALARA |
| protocol of optimization Philips | Device | protocol of opimization Philips |
Primary outcome
Comparison of the average dose per child, according to the protocol
Time frame: maximum one day per patient
1 secondary outcome
number of X-rays photographs according to the protocol, quality of photographs according to the protocol,
Time frame: maximum one day per patient
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Piotin principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protocol of optimization ALARA and protocol of optimization Philips in people with Occlusion or Malformation of a Cerebral Vessel, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the average dose per child, according to the protocol (time frame: maximum one day per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.