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.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Malformations; Aneurysm; Stenosis; Dural Arteriovenous Malformations
• Intervention / Treatment: Radiation: Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.; Radiation: Normal dose DSA with conventional X-ray technology

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna, Sweden, SE-171 76
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced radiation dose (ClarityIQ); Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology	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 Names: ClarityIQ
Active Comparator: Normal radiation dose (AlluraXper); Normal dose DSA with conventional X-ray technology.	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 Names: AlluraXper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose Measurements: Dose Area Product (DAP)	Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.	Participants were followed for the duration of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose Measurements: Air Kerma (AK)	Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.	Participants were followed for the duration of the procedure

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Philips Medical Systems
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Radiation exposure; X-ray; Image processing; Neuro angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Aneurysm
• Other Study ID Numbers: KUH-PMS-01