Image Quality and Radiation Dose in Angiography

NCT ID: NCT01381952

Last Updated: 2014-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.

Detailed Description

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The advent of interventional neuroradiology (INR) has changed the treatment of neurovascular diseases by reducing the procedural invasiveness and the recovery time needed by patients, thus improving clinical outcome. However, INR procedures often require many high-quality digital substraction angiography (DSA) runs and long total fluoroscopy times, which can result in patients being exposed to considerable radiation doses levels.

In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a real-time noise reduction algorithm for DSA in neuroradiology that is capable to reduce the patient entrance dose by 75% without loss of image quality.

Conditions

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Arteriovenous Malformations Aneurysm Stenosis Dural Arteriovenous Malformations

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Reduced radiation dose (ClarityIQ)

Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology

Group Type EXPERIMENTAL

Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.

Intervention Type RADIATION

Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.

Normal radiation dose (AlluraXper)

Normal dose DSA with conventional X-ray technology.

Group Type ACTIVE_COMPARATOR

Normal dose DSA with conventional X-ray technology

Intervention Type RADIATION

Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.

Interventions

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Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.

Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.

Intervention Type RADIATION

Normal dose DSA with conventional X-ray technology

Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.

Intervention Type RADIATION

Other Intervention Names

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ClarityIQ AlluraXper

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* Normal kidney function
* Neurologically intact
* Planned for diagnostic angiography or endovascular treatment

Exclusion Criteria

* Pregnancy
* Other conditions that limit the use of contrast media or ionizing radiation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Medical Systems

INDUSTRY

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Söderman

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Söderman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Tommy Andersson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Staffan Holmin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Solna, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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KUH-PMS-01

Identifier Type: -

Identifier Source: org_study_id

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