Image Quality and Radiation Dose in Angiography
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|ClinicalTrials.gov Identifier: NCT01381952|
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Malformations Aneurysm Stenosis Dural Arteriovenous Malformations||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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||XRES4 Neuro Claim Study|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Reduced radiation dose (ClarityIQ)
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.
Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.
Other Name: ClarityIQ
Active Comparator: Normal radiation dose (AlluraXper)
Normal dose DSA with conventional X-ray technology.
Radiation: Normal dose DSA with conventional X-ray technology
Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
Other Name: AlluraXper
- Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. [ Time Frame: 1 day ]
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.
- Radiation Dose Measurements: Dose Area Product (DAP) [ Time Frame: Participants were followed for the duration of the procedure ]Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.
- Radiation Dose Measurements: Air Kerma (AK) [ Time Frame: Participants were followed for the duration of the procedure ]Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381952
|Karolinska University Hospital|
|Solna, Sweden, SE-171 76|
|Principal Investigator:||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|