Image Quality and Radiation Dose in Angiography

This study has been completed.
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by (Responsible Party):
Michael Söderman, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01381952
First received: June 20, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: XRES4 Neuro Claim Study

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Radiation Dose Measurements: Dose Area Product (DAP) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
    Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.


Other Outcome Measures:
  • Radiation Dose Measurements: Air Kerma (AK) [ Time Frame: Participants were followed for the duration of the procedure ] [ Designated as safety issue: No ]
    Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381952

Locations
Sweden
Karolinska University Hospital
Solna, Sweden, SE-171 76
Sponsors and Collaborators
Karolinska University Hospital
Philips Medical Systems
Investigators
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
  More Information

No publications provided

Responsible Party: Michael Söderman, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01381952     History of Changes
Other Study ID Numbers: KUH-PMS-01
Study First Received: June 20, 2011
Results First Received: January 28, 2014
Last Updated: April 23, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
X-ray
Image processing
Neuro angiography
Radiation exposure

Additional relevant MeSH terms:
Congenital Abnormalities
Aneurysm
Arteriovenous Malformations
Hemangioma
Constriction, Pathologic
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 29, 2014