NCT01381952|CompletedResults
Image Quality and Radiation Dose in Angiography
XRES4 Neuro Claim Study
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XRES4 Neuro Claim Study
Sponsor study identifier
interventional
20
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
September 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2011
Actual (reported)June 27, 2011
Actual (reported)August 2011
Actual (reported)September 2011
Actual (reported)May 22, 2014
Actual (reported)Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.
The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics. A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA.
1 day
Radiation Dose Measurements: Dose Area Product (DAP)
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology
Normal dose DSA with conventional X-ray technology.
Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.
Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
Karolinska University Hospital
Solna, SE-171 76, Sweden
Michael Söderman, MD, PhD
Karolinska University Hospital
Tommy Andersson, MD, PhD
Karolinska University Hospital
Staffan Holmin, MD, PhD
Karolinska University Hospital
20 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2011
First Posted
June 27, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Participants were followed for the duration of the procedure
Radiation Dose Measurements: Air Kerma (AK)
Participants were followed for the duration of the procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2011
Actual (reported)Study Completion
September 2011
Actual (reported)Last Updated
May 22, 2014
Results First Posted
May 22, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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