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Image Quality and Radiation Dose in Angiography

This study has been completed.
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by (Responsible Party):
Michael Söderman, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01381952
First received: June 20, 2011
Last updated: April 23, 2014
Last verified: April 2014

June 20, 2011
April 23, 2014
June 2011
August 2011   (final data collection date for primary outcome measure)
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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.

Image Quality [ Time Frame: Within 30 days after procedure ] [ Designated as safety issue: No ]
Simultaneous visual comparison of image quality in the two groups, by three blinded reviewers. Image quality is assesed by following a specific test protocol regarding vessel visibility.
Complete list of historical versions of study NCT01381952 on ClinicalTrials.gov Archive Site
Radiation Dose Measurements: Dose Area Product (DAP) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.
Not Provided
Radiation Dose Measurements: Air Kerma (AK) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.
Not Provided
 
Image Quality and Radiation Dose in Angiography
XRES4 Neuro Claim Study

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Arteriovenous Malformations
  • Aneurysm
  • Stenosis
  • Dural Arteriovenous Malformations
  • Radiation: 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.
    Other Name: ClarityIQ
  • 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.
    Other Name: AlluraXper
  • Experimental: Reduced radiation dose (ClarityIQ)
    Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology
    Intervention: Radiation: Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.
  • Active Comparator: Normal radiation dose (AlluraXper)
    Normal dose DSA with conventional X-ray technology.
    Intervention: Radiation: Normal dose DSA with conventional X-ray technology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01381952
KUH-PMS-01
No
Michael Söderman, Karolinska University Hospital
Karolinska University Hospital
Philips Medical Systems
Principal Investigator: Michael Söderman, MD, PhD Karolinska University Hospital
Principal Investigator: Tommy Andersson, MD, PhD Karolinska University Hospital
Principal Investigator: Staffan Holmin, MD, PhD Karolinska University Hospital
Karolinska University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP