Clinical trial NCT01381952: Image Quality and Radiation Dose in Angiography
Official title: XRES4 Neuro Claim Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Malformations
Aneurysm
Stenosis
Dural Arteriovenous Malformations
Keywords: X-ray
Image processing
Neuro angiography
Radiation exposure
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2011-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.
timeFrame: 1 day
Secondary outcomes:
measure: Radiation Dose Measurements: Dose Area Product (DAP)
timeFrame: Participants were followed for the duration of the procedure
Other outcomes:
measure: Radiation Dose Measurements: Air Kerma (AK)
timeFrame: Participants were followed for the duration of the procedure
Locations:
city: Solna
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Michael Söderman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Tommy Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Staffan Holmin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: