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Image Quality and Radiation Dose in Angiography

Primary Purpose

Arteriovenous Malformations, Aneurysm, Stenosis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.
Normal dose DSA with conventional X-ray technology
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arteriovenous Malformations focused on measuring X-ray, Image processing, Neuro angiography, Radiation exposure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced radiation dose (ClarityIQ)

Normal radiation dose (AlluraXper)

Arm Description

Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology

Normal dose DSA with conventional X-ray technology.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Radiation Dose Measurements: Dose Area Product (DAP)
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.

Full Information

First Posted
June 20, 2011
Last Updated
April 23, 2014
Sponsor
Karolinska University Hospital
Collaborators
Philips Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01381952
Brief Title
Image Quality and Radiation Dose in Angiography
Official Title
XRES4 Neuro Claim Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Philips Medical Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Malformations, Aneurysm, Stenosis, Dural Arteriovenous Malformations
Keywords
X-ray, Image processing, Neuro angiography, Radiation exposure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced radiation dose (ClarityIQ)
Arm Type
Experimental
Arm Description
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology
Arm Title
Normal radiation dose (AlluraXper)
Arm Type
Active Comparator
Arm Description
Normal dose DSA with conventional X-ray technology.
Intervention Type
Radiation
Intervention Name(s)
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.
Other Intervention Name(s)
ClarityIQ
Intervention Description
Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.
Intervention Type
Radiation
Intervention Name(s)
Normal dose DSA with conventional X-ray technology
Other Intervention Name(s)
AlluraXper
Intervention Description
Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
Primary Outcome Measure Information:
Title
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Radiation Dose Measurements: Dose Area Product (DAP)
Description
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.
Time Frame
Participants were followed for the duration of the procedure
Other Pre-specified Outcome Measures:
Title
Radiation Dose Measurements: Air Kerma (AK)
Description
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.
Time Frame
Participants were followed for the duration of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Söderman, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tommy Andersson, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Staffan Holmin, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
SE-171 76
Country
Sweden

12. IPD Sharing Statement

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Image Quality and Radiation Dose in Angiography

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