Image Quality and Radiation Dose in Angiography

Aneurysm Clinical Trial

Official title:

XRES4 Neuro Claim Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381952
• Other study ID #: KUH-PMS-01
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: April 23, 2014
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Malformations
• Congenital Abnormalities
• Dural Arteriovenous Malformations
• Hemangioma
• Stenosis

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Solna

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Philips Medical Systems

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No