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NCT Number: NCT01381952

Image Quality and Radiation Dose in Angiography

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.

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Key information

Conditions

Arteriovenous Malformations Aneurysm Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Dural Arteriovenous Malformations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stenosis Vascular Diseases Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Solna, SE-171 76, Sweden

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

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

Other names: ClarityIQ

Normal dose DSA with conventional X-ray technology

Radiation

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

Other names: AlluraXper

Primary outcomes

  1. Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.

    Time frame: 1 day

    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.

Secondary outcomes

  1. Radiation Dose Measurements: Dose Area Product (DAP)

    Time frame: Participants were followed for the duration of the procedure

    Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.

Other outcomes

  1. Radiation Dose Measurements: Air Kerma (AK)

    Time frame: Participants were followed for the duration of the procedure

    Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Philips Medical Systems

Registry information

Official study title

XRES4 Neuro Claim Study

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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