NCT01599741

X-ray Dose Reduction Study for Endovascular Interventional Radiology

Clinical Validation and Evaluation of X-ray Image Processing for Endovascular Digital Subtraction Angiography and Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, shorter pulses and the introduction of automatic real-time motion compensation in subtraction imaging are used, which are known to positively influence image quality . The final effect on the clinical image quality in peripheral angiography is investigated in this study.

Detailed description

X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose. The primary aim of this study is to verify if the diagnostic image quality is equal or better when using a significant reduction in X-ray dose for endovascular digital subtraction angiography in combination with a novel imaging technology compared to using normal dose with conventional image technology.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
RADIATION	Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.	Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.
RADIATION	Normal dose DSA with conventional X-ray imaging technology	Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-05-16
• Last updated: 2022-03-08
• Results posted: 2014-03-05

Locations

1 site across 1 country: Netherlands