Pulmonary DiseaseNCT05645796
Improved Chest CT Diagnostic and Contrast Medium Administration
A study testing Adopted contrast media amount by using different approaches in people with Pulmonary Disease, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Investigation of impact of using different CM approaches on contrast enhancement in chest Ct examinations - A prospective study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Adopted contrast media amount by using different approaches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteNorway
- Study dates
- 2 Aug 2021to 15 Jan 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing chest CT examination between August 2019 and September 2021
- age > 18 years
Who cannot join
- hemodynamic instability
- cardiac failure
- pacemaker
- renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2)
- contraindications to contrast enhanced CT
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of impact of using different CM approaches on contrast enhancement in chest Ct examinations - A prospective study
Read the detailed description
Continuing advances in computed tomography (CT) in the past decades such as short scanning times with multi-detector CT (MDCT) requires contrast medium (CM) administration to be precisely planned to ensure a diagnostically accurate CT scans. To improve the chest CT diagnostic, the contrast enhancement in the thoracic vessels shoulde be increased.
The most important patient-related factors affecting the magnitude of vascular and parenchymal contrast enhancement are body weight. Historical practice has been to use a fixed volume of CM independent of body weight. Research has shown a clear relationship between vessel enhancement and patient weight, and that fixed CM volume technique is inappropriate, as smaller patients may receive excessive volume, and larger patients insufficient volume resulting in reduced image quality and poor diagnostic. In addition, excess CM can result in contrast induced adverse effects and nephropathy. To overcome these problems, it is essential to adjust the CM volume to the patient's total body weight and body composition. This adjustment can be done in different ways. The aim of this study is to identify which weight/body tailored CM administration is the best replacement for fixed CM administration in chest CT. The cost and procedure time will also be explored.
- Conditions
- Pulmonary Disease
- Being tested
- Adopted contrast media amount by using different approaches
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adopted contrast media amount by using different approachesOther
Using different contrast media approaches recommended by literature to explore the impact on the contrast enhancement in chest CT
| Study group | Role | What they receive |
|---|---|---|
| Fixed group | Active comparator | They received a fixed amount of contrast media prior to CT scan Receives: Other: Adopted contrast media amount by using different approaches |
| body composition tailored group | Active comparator | They received a body tailored amount of contrast media prior to CT scan Receives: Other: Adopted contrast media amount by using different approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast medium protocols in routine chest CT - A survey study
survey of what kind of contrast medium approaches are used in European hospitals
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start2 Aug 2021
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups receiving contrast medium based on different approaches are included and compared with each other
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Safora Johansen, Oslo Metropolitan University
- Investigators
- Safora F Johansen, PhD, Study director, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645796
- Sponsor's protocol ID
- 2016/674
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henning MK, Gunn C, Arenas-Jimenez J, Johansen S. Strategies for calculating contrast media dose for chest CT. Eur Radiol Exp. 2023 Jun 12;7(1):29. doi: 10.1186/s41747-023-00345-w.
PubMed 37303003
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Chest CT Diagnostic and Contrast Medium Administration
- ClinicalTrials.gov ID
- NCT05645796
- Acronym / sponsor ID
- 2016/674
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 12 Dec 2022 (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.
Investigation of impact of using different CM approaches on contrast enhancement in chest Ct examinations - A prospective study
Detailed description
Continuing advances in computed tomography (CT) in the past decades such as short scanning times with multi-detector CT (MDCT) requires contrast medium (CM) administration to be precisely planned to ensure a diagnostically accurate CT scans. To improve the chest CT diagnostic, the contrast enhancement in the thoracic vessels shoulde be increased.
The most important patient-related factors affecting the magnitude of vascular and parenchymal contrast enhancement are body weight. Historical practice has been to use a fixed volume of CM independent of body weight. Research has shown a clear relationship between vessel enhancement and patient weight, and that fixed CM volume technique is inappropriate, as smaller patients may receive excessive volume, and larger patients insufficient volume resulting in reduced image quality and poor diagnostic. In addition, excess CM can result in contrast induced adverse effects and nephropathy. To overcome these problems, it is essential to adjust the CM volume to the patient's total body weight and body composition. This adjustment can be done in different ways. The aim of this study is to identify which weight/body tailored CM administration is the best replacement for fixed CM administration in chest CT. The cost and procedure time will also be explored.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups receiving contrast medium based on different approaches are included and compared with each other
| Arm | Type | Receives |
|---|---|---|
| Fixed group | Active comparator | Other: Adopted contrast media amount by using different approachesThey received a fixed amount of contrast media prior to CT scan |
| body composition tailored group | Active comparator | Other: Adopted contrast media amount by using different approachesThey received a body tailored amount of contrast media prior to CT scan |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing chest CT examination between August 2019 and September 2021
- age > 18 years
Key exclusion criteria (6 listed)
- hemodynamic instability
- cardiac failure
- pacemaker
- renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.73 m2)
- contraindications to contrast enhanced CT
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 |
|---|---|---|
| Adopted contrast media amount by using different approachesUsing different contrast media approaches recommended by literature to explore the impact on the contrast enhancement in chest CT | Other | Fixed group, body composition tailored group |
Primary outcome
Contrast medium protocols in routine chest CT - A survey study
Time frame: 15 months
survey of what kind of contrast medium approaches are used in European hospitals
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 29 Mar 2023.
- Derived from this study: PubMed 37303003Henning MK, Gunn C, Arenas-Jimenez J, Johansen S. Strategies for calculating contrast media dose for chest CT. Eur Radiol Exp. 2023 Jun 12;7(1):29. doi: 10.1186/s41747-023-00345-w.
- Individual participant dataSharing planned: No
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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.
Safora F Johansen, PhD study director
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adopted contrast media amount by using different approaches in people with Pulmonary Disease, run by Oslo Metropolitan University 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 2 inclusion and 6 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 29 Mar 2023. 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.
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?
Contrast medium protocols in routine chest CT - A survey study (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645796, which also lists 1 linked publication.
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 29 Mar 2023.