Pulmonary EmbolismNCT05592444
Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography
A study testing Low iodine Spectral Detector CT Pulmonary Angiography in people with Pulmonary Embolism, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA). 330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Low iodine Spectral Detector CT Pulmonary Angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteNorway
- Study dates
- 23 Nov 2020to 12 Oct 2021
- 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
- Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
- Patients with clinical suspicion of disease of PE
- Referral to CTPA diagnosis, treatment planning or follow-up.
- Peripheral venous catheter (PVC) =/< 18 G
Who cannot join
- Contraindication to iodinated contrast medium
- Age < 18 years
- Lack of informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).
330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection.
Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.
Read the detailed description
Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose.
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).
330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg).
Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.
- Conditions
- Pulmonary Embolism
- Being tested
- Low iodine Spectral Detector CT Pulmonary Angiography
- Keywords
- Pulmonary Embolism, Spectral Detector CT, Contrast medium
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low iodine Spectral Detector CT Pulmonary AngiographyDiagnostic test
Low iodine Spectral Detector CT Pulmonary Angiography
| Study group | Role | What they receive |
|---|---|---|
| Low concentration | Experimental | Patients receive a contrast medium with an iodine concentration of 140 mg/ml. The volume is 1 ml/kg which result in a dose of 140 mg/kg.
Maximal dose of contrast medium is 90 ml i.e. 12.6 g of iodine. Receives: Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography |
| Low volume | Experimental | Patients receive a contrast medium with an iodine concentration 350 of mg/ml. The volume is 0.4 ml/kg which result in a dose of 140 mg/kg.
Maximal dose of contrast medium is 36 ml i.e. 12.6 g of iodine. Receives: Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography |
| Saline Dilution | Experimental | Patients receive a contrast medium with an iodine concentration of 350 mg/ml. The contrast medium is diluted 1:1 with saline.
The injected volume is 0.8 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 72 ml i.e. 12.6 g of iodine. Receives: Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast enhancement (Vascular attenuation)
Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination
Measured: Measured on the CT images from the examination performed at enrollment
Secondary outcomes (3)
Homogeneity of contrast enhancement (image noise)
Homogeneity of contrast enhancement is measured as the standard deviation of attenuation in the pulmonary artery branches (equals image noise).
Measured: Measured on the CT images from the examination performed at enrollment
Contrast to noise ratio (CNR)
CNR is measured as (Vascular attenuation - Muscular attenuation) / Image noise
Measured: Measured on the CT images from the examination performed at enrollment
Signal to noise ratio (SNR)
SNR is measured as Vascular attenuation / Image noise
Measured: Measured on the CT images from the examination performed at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start23 Nov 2020
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- Patients are randomly assigned to one of three injection methods: low concentration, low-volume and saline-dilution.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Maehre Lauritzen, University Hospital, Akershus
- Investigators
- Peter M Lauritzen, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592444
- Sponsor's protocol ID
- 142126
- Status last verified
- Apr 2024
- First submitted
- 20 Oct 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT
- ClinicalTrials.gov ID
- NCT05592444
- Acronym / sponsor ID
- 142126
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Spectral Detector CT, Contrast medium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 24 Oct 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.
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).
330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection.
Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.
Detailed description
Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose.
The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).
330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg).
Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are randomly assigned to one of three injection methods: low concentration, low-volume and saline-dilution.
| Arm | Type | Receives |
|---|---|---|
| Low concentration | Experimental | Diagnostic Test: Low iodine Spectral Detector CT Pulmonary AngiographyPatients receive a contrast medium with an iodine concentration of 140 mg/ml. The volume is 1 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 90 ml i.e. 12.6 g of iodine. |
| Low volume | Experimental | Diagnostic Test: Low iodine Spectral Detector CT Pulmonary AngiographyPatients receive a contrast medium with an iodine concentration 350 of mg/ml. The volume is 0.4 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 36 ml i.e. 12.6 g of iodine. |
| Saline Dilution | Experimental | Diagnostic Test: Low iodine Spectral Detector CT Pulmonary AngiographyPatients receive a contrast medium with an iodine concentration of 350 mg/ml. The contrast medium is diluted 1:1 with saline. The injected volume is 0.8 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 72 ml i.e. 12.6 g of iodine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
- Patients with clinical suspicion of disease of PE
- Referral to CTPA diagnosis, treatment planning or follow-up.
- Peripheral venous catheter (PVC) =/< 18 G
Key exclusion criteria (4 listed)
- Contraindication to iodinated contrast medium
- Age < 18 years
- Lack of informed consent
- Pregnancy
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 iodine Spectral Detector CT Pulmonary AngiographyLow iodine Spectral Detector CT Pulmonary Angiography | Diagnostic test | Low concentration, Low volume, Saline Dilution |
Primary outcome
Contrast enhancement (Vascular attenuation)
Time frame: Measured on the CT images from the examination performed at enrollment
Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination
3 secondary outcomes
Homogeneity of contrast enhancement (image noise)
Time frame: Measured on the CT images from the examination performed at enrollment
Contrast to noise ratio (CNR)
Time frame: Measured on the CT images from the examination performed at enrollment
Signal to noise ratio (SNR)
Time frame: Measured on the CT images from the examination performed at enrollment
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 16 Apr 2024.
- 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.
Peter M Lauritzen, PhD principal investigator
University Hospital, Akershus
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 iodine Spectral Detector CT Pulmonary Angiography in people with Pulmonary Embolism, run by University Hospital, Akershus 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 4 inclusion and 4 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 16 Apr 2024. 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 enhancement (Vascular attenuation) (time frame: Measured on the CT images from the examination performed at enrollment). 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 16 Apr 2024.