Image Quality and Radiation Dose in Angiography

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
XRES4 Neuro Claim Study

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced radiation dose (ClarityIQ)<br>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.<br>* Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.<br>* Other names: ClarityIQ;|
| Active Comparator: Normal radiation dose (AlluraXper)<br>Normal dose DSA with conventional X-ray technology. | Radiation: Normal dose DSA with conventional X-ray technology<br>* Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
X-ray, Image processing, Neuro angiography, Radiation exposure