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| Name | Class |
|---|---|
| Philips Medical Systems | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced radiation dose (ClarityIQ) | Experimental | Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology |
|
| Normal radiation dose (AlluraXper) | Active Comparator | Normal dose DSA with conventional X-ray technology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology. | Radiation | Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Söderman, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Tommy Andersson, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Staffan Holmin, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Solna | SE-171 76 | Sweden |
20 patients enrolled the study; 16 patients were undergoing diagnostic neuroangiography and 4 were undergoing INR procedures for different pathological conditions. All signed patient consent.
The enrollment of patients occurred between 22 June 2011 and 11 August 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | AlluraXper - ClarityIQ | Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AlluraXper - ClarityIQ | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AlluraXper - ClarityIQ | Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Söderman | Karolinska University Hospital | +46851774037 | michael.soderman@karolinska.se |
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D000783 | Aneurysm |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| Normal dose DSA with conventional X-ray technology | Radiation | Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| AlluraXper |
Angiogram with AlluraXper followed by angiogram with ClarityIQ |
| OG001 | Allura Clarity | Angiogram with AlluraXper followed by angiogram with ClarityIQ |
|
|
| 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. | All patients with recorded dose information and images for both angiograms were included (n=20) | Posted | Mean | Standard Deviation | percentage of dose reduction | Participants were followed for the duration of the procedure |
|
|
|
| Other Pre-specified | Radiation Dose Measurements: Air Kerma (AK) | Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. | All patients with recorded dose information and images for both angiograms were included (n=20) | Posted | Mean | Standard Deviation | percentage of dose reduction | Participants were followed for the duration of the procedure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |