X-ray Dose Reduction Study for Endovascular Interventional Radiology

Philips

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Radiation: Normal dose DSA with conventional X-ray imaging technology; Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599741

XCY607-100093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients older than 18 years of age undergoing digital subtraction angiography for diagnosis or treatment of iliac artery disease.

Exclusion criteria

• Patients not willing or unable to give consent to participate
• Patients already involved in a clinical trial
• Patients under the age of 18
• Pregnant or breastfeeding women
• Patients with kidney disease (eGFR < 60)

Trial design

51 participants in 2 patient groups

ClarityIQ

Experimental group

Description:

Low-dose DSA (83% reducation compared to normal dose) with novel X-ray imaging technology.

Treatment:

Radiation: Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.

AlluraXper

Active Comparator group

Description:

Normal dose DSA with conventional X-ray imaging technology.

Treatment:

Radiation: Normal dose DSA with conventional X-ray imaging technology