Image Quality and Radiation Dose in Angiography

NCT01381952 | Completed Results

• 1 other identifier: KUH-PMS-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Malformations; Aneurysm; Stenosis; Dural Arteriovenous Malformations

Keywords

X-ray; Image processing; Neuro angiography; Radiation exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiation Dose Measurements: Dose Area Product (DAP)

  Participants were followed for the duration of the procedure

Other Outcomes (1)

• Radiation Dose Measurements: Air Kerma (AK)

  Participants were followed for the duration of the procedure

Study Arms (2)

Reduced radiation dose (ClarityIQ)

EXPERIMENTAL

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.

Normal radiation dose (AlluraXper)

ACTIVE COMPARATOR

Normal dose DSA with conventional X-ray technology.

Radiation: Normal dose DSA with conventional X-ray technology

Interventions

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.

Also known as: ClarityIQ

Reduced radiation dose (ClarityIQ)

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.

Also known as: AlluraXper

Normal radiation dose (AlluraXper)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Normal kidney function
• Neurologically intact
• Planned for diagnostic angiography or endovascular treatment

You may not qualify if:

• Pregnancy
• Other conditions that limit the use of contrast media or ionizing radiation

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Philips Medical Systems: collaborator

Study Sites (1)

Karolinska University Hospital

Solna, SE-171 76, Sweden

Location

MeSH Terms

Conditions

Arteriovenous Malformations; Aneurysm; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Söderman
• Organization: Karolinska University Hospital

michael.soderman@karolinska.se

+46851774037

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 22, 2014
• Results First Posted: May 22, 2014

Record last verified: 2014-04

Locations

SE (1)