Pulmonary Embolus/EmboliNCT04859478
Venous Phase Dual Energy CT in Patients Suspected for Pulmonary Embolism.
A study testing Dual energy / spectral portal venous chest computed tomography in people with Pulmonary Embolus/Emboli and Thromboembolism, Pulmonary, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
Trial summary
Venous phase spectral or dual energy (DE) chest computed tomography (CT) in patients with suspected pulmonary embolism (PE) compared to standard computed tomography pulmonary angiography (CTPA): sensitivity, evaluation of iodine mapping and incidental findings. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Embolus/Emboli, Thromboembolism, Pulmonary
- What is being tested?
- Dual energy / spectral portal venous chest computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2021to 31 Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suspected for pulmonary embolism undergoing a computed tomography pulmonary angiography
- Minimum age 50 years
Who cannot join
- Temporarily or permanently incompetent patient not able to give informed consent
- No informed consent obtained for other reasons
- Allergic to iodine based contrast media
- Impaired renal function
- Patients with thyreotoxicosis
- Non-diagnostic quality of computed tomography images
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Copenhagen University Gentofte Hospital
Copenhagen, Hellerup, 2900
Liva J Spindler, MD
- Recruiting
Copenhagen University Hospital, Herlev Hospital
Copenhagen, Herlev, 2400
Louis L Plesner
About this study
Official title: Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.
Venous phase spectral or dual energy (DE) chest computed tomography (CT) in patients with suspected pulmonary embolism (PE) compared to standard computed tomography pulmonary angiography (CTPA): sensitivity, evaluation of iodine mapping and incidental findings.
Read the detailed description
Background/rationale: DE CTPA provides additional anatomical and functional information in the investigation of PE, especially in regards of iodine uptake in pulmonary vasculature and lung parenchyma. Postprocessing techniques improve visualisation of low concentrations of iodine contrast media.This has shown potential in reducing the amount of contrast media, salvaging scans with suboptimal contrast enhancement and for improving visualisation of incidental pulmonary embolisms in portal venous chest CT scans. Other significant DE postprocessing techniques include the substraction of iodine, creating virtual non-contrast images in addition to the dual energy. This technique has proven useful in evaluation of different thoracic and abdominal parenchymal lesions.
Objective: To evaluate sensitivity of chest DECT in portal venous phase in the diagnosis of PE compared to standard care DE CTPA. Furthermore, the prevalence and management of incidental findings will be evaluated.
Design: Patients enrolled in this study will undergo a venous phase chest DE CT in addition to standard care DE CTPA. The two scans will be performed consecutively using the same contrast media bolus. Standard DE reconstructions of all scans will be obtained for radiological evaluation and reporting in regards of suspected PE.
Both scans with standard DE reconstructions will be available for clinical evaluation and patient care in the standard care AGFA PACS system. Radiological reading and reporting will be performed as usual in the clinical setting.
For research purposes, additional post-processing procedures may be performed by the readers in Philips IntelliSpace Portal or Siemens Syngo.via depending on the scanner applied. The standard CTPA will be interpreted by a thoracic radiologist and used as reference. The corresponding portal venous chest CT will be interpreted individually by two other certified radiologists in order to avoid recall bias. In case of disagreement in the venous chest CT, an independent radiologist not elsewhere involved will be consulted. If a PE detected on the portal venous scan is not detected on the reference CTPA, the reference reader will re-evaluate the CTPA.
Patient characteristics, clinical information, radiation dose, contrast media, clinical diagnosis, incidental findings and recommendations of further clinical management according to clinical guidelines will be recorded in a secure web-based database.
Study population: Patients aged ≥50 with suspected pulmonary embolism who are having performed a standard care CTPA.
- Being tested
- Dual energy / spectral portal venous chest computed tomography
- Keywords
- CT, CTPA, Computed tomography, Computed tomography pulmonary angiography, Dual energy, Spectral, Sensitivity, Incidental findings, Iodine mapping, Radiology, Imaging, Diagnostic accuracy
- Medical subject headings
- Pulmonary Embolism, Embolism, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual energy / spectral portal venous chest computed tomographyDiagnostic test
Each patient undergoes an additional dual energy / spectral chest CT in addition to standard care CTPA. The intervention is performed immediately after standard care CTPA.
| Study group | Role | What they receive |
|---|---|---|
| All eligible patients | Other | All patients undergo the same CT protocol in addition to standard care. Receives: Diagnostic Test: Dual energy / spectral portal venous chest computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Measured: through study completion, approx. of 1 year
Specificity
Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Measured: through study completion, approx. 1 year
Secondary outcomes (4)
Sensitivity
Lobe and segment based sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Measured: through study completion, approx. of 1 year
Specificity
Lobe and segment based specificicty of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Measured: through study completion, approx. of 1 year
Incidental findings
Evaluation and management of incidental findings in portal venous phase chest CT compared to standard care CTPA.
Measured: through study completion, approx. of 1 year
Iodine mapping
Comparison of perfusion defects on iodine mapping between portal venous chest CT and CTPA. Descriptive.
Measured: through study completion, approx. of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolus/EmboliStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yecatarina Zincuk Rohde, MD, Copenhagen University Hospital at Herlev
- Investigators
- Yecatarina Z Rohde, MD, Principal investigator, Copenhagen University Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859478
- Sponsor's protocol ID
- H-20035522
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 26 Apr 2021
- 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 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.
- ClinicalTrials.gov ID
- NCT04859478
- Acronym / sponsor ID
- H-20035522
- Keywords
- CT, CTPA, Computed tomography, Computed tomography pulmonary angiography, Dual energy, Spectral, Sensitivity, Incidental findings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Apr 2021 (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.
Venous phase spectral or dual energy (DE) chest computed tomography (CT) in patients with suspected pulmonary embolism (PE) compared to standard computed tomography pulmonary angiography (CTPA): sensitivity, evaluation of iodine mapping and incidental findings.
Detailed description
Background/rationale: DE CTPA provides additional anatomical and functional information in the investigation of PE, especially in regards of iodine uptake in pulmonary vasculature and lung parenchyma. Postprocessing techniques improve visualisation of low concentrations of iodine contrast media.This has shown potential in reducing the amount of contrast media, salvaging scans with suboptimal contrast enhancement and for improving visualisation of incidental pulmonary embolisms in portal venous chest CT scans. Other significant DE postprocessing techniques include the substraction of iodine, creating virtual non-contrast images in addition to the dual energy. This technique has proven useful in evaluation of different thoracic and abdominal parenchymal lesions.
Objective: To evaluate sensitivity of chest DECT in portal venous phase in the diagnosis of PE compared to standard care DE CTPA. Furthermore, the prevalence and management of incidental findings will be evaluated.
Design: Patients enrolled in this study will undergo a venous phase chest DE CT in addition to standard care DE CTPA. The two scans will be performed consecutively using the same contrast media bolus. Standard DE reconstructions of all scans will be obtained for radiological evaluation and reporting in regards of suspected PE.
Both scans with standard DE reconstructions will be available for clinical evaluation and patient care in the standard care AGFA PACS system. Radiological reading and reporting will be performed as usual in the clinical setting.
For research purposes, additional post-processing procedures may be performed by the readers in Philips IntelliSpace Portal or Siemens Syngo.via depending on the scanner applied. The standard CTPA will be interpreted by a thoracic radiologist and used as reference. The corresponding portal venous chest CT will be interpreted individually by two other certified radiologists in order to avoid recall bias. In case of disagreement in the venous chest CT, an independent radiologist not elsewhere involved will be consulted. If a PE detected on the portal venous scan is not detected on the reference CTPA, the reference reader will re-evaluate the CTPA.
Patient characteristics, clinical information, radiation dose, contrast media, clinical diagnosis, incidental findings and recommendations of further clinical management according to clinical guidelines will be recorded in a secure web-based database.
Study population: Patients aged ≥50 with suspected pulmonary embolism who are having performed a standard care CTPA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All eligible patients | Other | Diagnostic Test: Dual energy / spectral portal venous chest computed tomographyAll patients undergo the same CT protocol in addition to standard care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suspected for pulmonary embolism undergoing a computed tomography pulmonary angiography
- Minimum age 50 years
Key exclusion criteria (6 listed)
- Temporarily or permanently incompetent patient not able to give informed consent
- No informed consent obtained for other reasons
- Allergic to iodine based contrast media
- Impaired renal function
- Patients with thyreotoxicosis
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 |
|---|---|---|
| Dual energy / spectral portal venous chest computed tomographyEach patient undergoes an additional dual energy / spectral chest CT in addition to standard care CTPA. The intervention is performed immediately after standard care CTPA. | Diagnostic test | All eligible patients |
Primary outcome
Sensitivity
Time frame: through study completion, approx. of 1 year
Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificity
Time frame: through study completion, approx. 1 year
Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
4 secondary outcomes
Sensitivity
Time frame: through study completion, approx. of 1 year
Specificity
Time frame: through study completion, approx. of 1 year
Incidental findings
Time frame: through study completion, approx. of 1 year
Iodine mapping
Time frame: through study completion, approx. of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- 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.
Yecatarina Z Rohde, MD principal investigator
Copenhagen University Herlev Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual energy / spectral portal venous chest computed tomography in people with Pulmonary Embolus/Emboli and Thromboembolism, Pulmonary, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yecatarina Zincuk Z Rohde, MD (+4560222733, katjazincuk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: through study completion, approx. of 1 year). The study lists 2 primary outcomes in all. 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 26 Apr 2021.