Arteriovenous MalformationsNCT01381952
Image Quality and Radiation Dose in Angiography
A study testing Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray technology in people with Arteriovenous Malformations and Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Malformations, Aneurysm, Stenosis
- What is being tested?
- Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Normal kidney function
- Neurologically intact
- Planned for diagnostic angiography or endovascular treatment
Who cannot join
- Pregnancy
- Other conditions that limit the use of contrast media or ionizing radiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XRES4 Neuro Claim Study
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.
Read the 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.
- Being tested
- Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray technology
- Keywords
- X-ray, Image processing, Neuro angiography, Radiation exposure
- Medical subject headings
- Arteriovenous Malformations, Aneurysm, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.Radiation
Also called ClarityIQ
Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.
Normal dose DSA with conventional X-ray technologyRadiation
Also called AlluraXper
Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
| Study group | Role | What they receive |
|---|---|---|
| Reduced radiation dose (ClarityIQ) | Experimental | Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology Receives: 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. Receives: Radiation: Normal dose DSA with conventional X-ray technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Radiation Dose Measurements: Dose Area Product (DAP)
Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.
Measured: Participants were followed for the duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arteriovenous MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems
- Responsible party
- Principal investigator, Michael Söderman, Karolinska University Hospital
- Investigators
- Michael Söderman, MD, PhD, Principal investigator, Karolinska University HospitalTommy Andersson, MD, PhD, Principal investigator, Karolinska University HospitalStaffan Holmin, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381952
- Sponsor's protocol ID
- KUH-PMS-01
- Status last verified
- Apr 2014
- First submitted
- 20 Jun 2011
- Last updated
- 22 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XRES4 Neuro Claim Study
- ClinicalTrials.gov ID
- NCT01381952
- Acronym / sponsor ID
- KUH-PMS-01
- Keywords
- X-ray, Image processing, Neuro angiography, Radiation exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Philips Medical Systems
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 22 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced radiation dose (ClarityIQ) | Experimental | Radiation: Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology |
| Normal radiation dose (AlluraXper) | Active comparator | Radiation: Normal dose DSA with conventional X-ray technologyNormal dose DSA with conventional X-ray technology. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- Normal kidney function
- Neurologically intact
- Planned for diagnostic angiography or endovascular treatment
Key exclusion criteria (2 listed)
- Pregnancy
- Other conditions that limit the use of contrast media or ionizing radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.Also: ClarityIQDigital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology. | Radiation | Reduced radiation dose (ClarityIQ) |
| Normal dose DSA with conventional X-ray technologyAlso: AlluraXperDigital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology. | Radiation | Normal radiation dose (AlluraXper) |
Primary outcome
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.
1 secondary outcome
Radiation Dose Measurements: Dose Area Product (DAP)
Time frame: Participants were followed for the duration of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Söderman, MD, PhD principal investigator
Karolinska University Hospital
Tommy Andersson, MD, PhD principal investigator
Karolinska University Hospital
Staffan Holmin, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology. and Normal dose DSA with conventional X-ray technology in people with Arteriovenous Malformations and Aneurysm, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.