Image Quality and Radiation Dose in Angiography

Karolinska University Hospital

Status: Completed

Conditions: Aneurysm; Arteriovenous Malformations; Dural Arteriovenous Malformations; Stenosis

Treatments: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01381952

KUH-PMS-01

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 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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Reduced radiation dose (ClarityIQ)

Experimental group

Description:

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

Treatment:

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

Normal radiation dose (AlluraXper)

Active Comparator group

Description:

Normal dose DSA with conventional X-ray technology.

Treatment:

Radiation: Normal dose DSA with conventional X-ray technology