Radiography, ThoracicNCT04300972
Comparison of Contrast Agent Administration Protocols
A study testing Body/weight adaption and Standard dose in people with Radiography, Thoracic, run by Oslo University Hospital.
Trial summary
The will compare two different ways of administering contrast media in CT exams of the chest: 1. a fixed dose of contrast medium 2. a weight- and body-type-adapted dose of contrast medium The goal is to see if one protocol is superior to the other in reliably producing diagnostic CT images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiography, Thoracic
- What is being tested?
- Body/weight adaption and Standard dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to 15 Oct 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- impaired renal function (glomerular filtration rate <60 ml/min)
- congenital heart disease (as indicated by referral)
- congestive heart failure (as indicated by referral)
About this study
The will compare two different ways of administering contrast media in CT exams of the chest:
- a fixed dose of contrast medium
- a weight- and body-type-adapted dose of contrast medium
The goal is to see if one protocol is superior to the other in reliably producing diagnostic CT images.
Read the detailed description
The continuing advances in computed tomographic (CT) technology in the past decades have provided ongoing opportunities to improve CT image quality, clinical practice and discover new clinical CT imaging applications. New CT technology, however, has introduced new challenges in clinical radiology practice. One of the challenges deals with intravenous contrast medium (CM) administration. Although multidetector CT allows more efficient and flexible use of contrast medium than single-detector CT, to fully reap the benefits of multidetector CT, certain technical challenges involving maximum contrast enhancement and optimal contrast material delivery must be met (1). While CT technology has evolved, the practice of CT intravenous CM administration has been continually debated and updated. The users of new CT technology, accompanied with its newly added technical complexity, discover they fall short of achieving a desired image quality with the traditional standard administration of CM. This entails a change in practice. In the department of Radiology at St Olav University Hospital (SOH), a new protocol for CM administration is now developed and is ready for implementation. This protocol is based on a body weight adapted CM administration, while the current protocol has a fixed CM injection. In this study, this newly CM administration protocol for thoracic CT will be compared to the fixed CM injection protocol. To our knowledge, very few studies (2) have been published on the use of body weight adapted injection protocols for Thoracic CT. Most of the studies report the impact of body weight adapted CM injection protocols for the coronary arteries of CT angiography (3- 5). Therefore, the aim of this study is to determine whether individually tailored protocol(s) for the injection of CM results in higher and more homogeneous vascular attenuation at thoracic CT compared with conventional injection protocols using fixed injection parameters. We know that to achieve optimal contrast enhancement in thoracic CT involves essential factors such as CT tube voltage and CT attenuation, patient factors, CM factors and CT scanning factors (1) and thus all these factors will be addressed and discussed in this investigation.
Specific aims of the study:
- To assess and compare the CT attenuation achieved with both protocols
- Compare the required amount of CM using weight adapted CM protocol and fixed CM injection protocol
- Compare the quality of the images using weight adapted CM protocol and fixed CM injection protocol
- Conditions
- Radiography, Thoracic
- Being tested
- Body/weight adaption, Standard dose
- Keywords
- computed tomography, contrast dose, weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body/weight adaptionDiagnostic test
contrast media dose is adapted to weight and body type
Standard doseDiagnostic test
a fixed amount of contrast media is used, independently of weight and body type
| Study group | Role | What they receive |
|---|---|---|
| fixed dose | Other | Not described Receives: Diagnostic Test: Standard dose |
| weight and body type adapted dose | Experimental | Not described Receives: Diagnostic Test: Body/weight adaption |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT density of large vessel, measured in Hounsfield units (HU) in the imaging software (PACS)
Measured: immediately after imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start15 Jun 2016
- Primary completion15 Oct 2016
- Study completion15 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiography, ThoracicStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Principal investigator, Kristian Fosså, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300972
- Sponsor's protocol ID
- CMProtokoll
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contrast Agent Administration Protocols
- ClinicalTrials.gov ID
- NCT04300972
- Acronym / sponsor ID
- CMProtokoll
- Conditions
- Radiography, Thoracic
- Keywords
- computed tomography, contrast dose, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 9 Mar 2020 (actual)
- 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.
The will compare two different ways of administering contrast media in CT exams of the chest:
- a fixed dose of contrast medium
- a weight- and body-type-adapted dose of contrast medium
The goal is to see if one protocol is superior to the other in reliably producing diagnostic CT images.
Detailed description
The continuing advances in computed tomographic (CT) technology in the past decades have provided ongoing opportunities to improve CT image quality, clinical practice and discover new clinical CT imaging applications. New CT technology, however, has introduced new challenges in clinical radiology practice. One of the challenges deals with intravenous contrast medium (CM) administration. Although multidetector CT allows more efficient and flexible use of contrast medium than single-detector CT, to fully reap the benefits of multidetector CT, certain technical challenges involving maximum contrast enhancement and optimal contrast material delivery must be met (1). While CT technology has evolved, the practice of CT intravenous CM administration has been continually debated and updated. The users of new CT technology, accompanied with its newly added technical complexity, discover they fall short of achieving a desired image quality with the traditional standard administration of CM. This entails a change in practice. In the department of Radiology at St Olav University Hospital (SOH), a new protocol for CM administration is now developed and is ready for implementation. This protocol is based on a body weight adapted CM administration, while the current protocol has a fixed CM injection. In this study, this newly CM administration protocol for thoracic CT will be compared to the fixed CM injection protocol. To our knowledge, very few studies (2) have been published on the use of body weight adapted injection protocols for Thoracic CT. Most of the studies report the impact of body weight adapted CM injection protocols for the coronary arteries of CT angiography (3- 5). Therefore, the aim of this study is to determine whether individually tailored protocol(s) for the injection of CM results in higher and more homogeneous vascular attenuation at thoracic CT compared with conventional injection protocols using fixed injection parameters. We know that to achieve optimal contrast enhancement in thoracic CT involves essential factors such as CT tube voltage and CT attenuation, patient factors, CM factors and CT scanning factors (1) and thus all these factors will be addressed and discussed in this investigation.
Specific aims of the study:
- To assess and compare the CT attenuation achieved with both protocols
- Compare the required amount of CM using weight adapted CM protocol and fixed CM injection protocol
- Compare the quality of the images using weight adapted CM protocol and fixed CM injection protocol
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixed dose | Other | Diagnostic Test: Standard dose |
| weight and body type adapted dose | Experimental | Diagnostic Test: Body/weight adaption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- impaired renal function (glomerular filtration rate <60 ml/min)
- congenital heart disease (as indicated by referral)
- congestive heart failure (as indicated by referral)
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 |
|---|---|---|
| Body/weight adaptioncontrast media dose is adapted to weight and body type | Diagnostic test | weight and body type adapted dose |
| Standard dosea fixed amount of contrast media is used, independently of weight and body type | Diagnostic test | fixed dose |
Primary outcome
CT density of large vessel, measured in Hounsfield units (HU) in the imaging software (PACS)
Time frame: immediately after imaging
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 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Body/weight adaption and Standard dose in people with Radiography, Thoracic, run by Oslo University Hospital.
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 0 inclusion and 3 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
CT density of large vessel, measured in Hounsfield units (HU) in the imaging software (PACS) (time frame: immediately after imaging). 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 9 Mar 2020.