Radiation ProtectionPhase 1NCT01059032
Enhancement and Restoring of Low Dose Abdominal CT Images
A Phase 1 study testing Using a 3 dimentional post processing filter in people with Radiation Protection, run by Lars Borgen at 1 site in Norway.
Trial summary
Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiation Protection
- What is being tested?
- Using a 3 dimentional post processing filter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.
Who cannot join
- Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study
Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.
- Conditions
- Radiation Protection
- Being tested
- Using a 3 dimentional post processing filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a 3 dimentional post processing filterOther
Using a 3 dimentional post processing filter
| Study group | Role | What they receive |
|---|---|---|
| Unenhanced images | No intervention | Not described |
| Enhanced images | Other | Enhanced images Receives: Other: Using a 3 dimentional post processing filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating of image quality
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProtectionStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Borgen
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Buskerud HF
- Responsible party
- Sponsor-investigator, Lars Borgen, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059032
- Sponsor's protocol ID
- 15017044793
- Status last verified
- Nov 2009
- First submitted
- 21 Jan 2010
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study
- ClinicalTrials.gov ID
- NCT01059032
- Acronym / sponsor ID
- 15017044793
- Conditions
- Radiation Protection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lars BorgenUniversity, hospital or other
- Collaborators
- Sykehuset Buskerud HF
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unenhanced images | No intervention | – |
| Enhanced images | Other | Other: Using a 3 dimentional post processing filterEnhanced images |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.
Key exclusion criteria (1 listed)
- Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast
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 |
|---|---|---|
| Using a 3 dimentional post processing filterUsing a 3 dimentional post processing filter | Other | Enhanced images |
Primary outcome
Rating of image quality
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Using a 3 dimentional post processing filter in people with Radiation Protection, run by Lars Borgen at 1 site in Norway.
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 1 inclusion and 1 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 2 Jun 2015. 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 Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rating of image quality (time frame: 3-6 months). 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 2 Jun 2015.