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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Yecatarina Zincuk Z Rohde, MD contact

+4560222733

katjazincuk@hotmail.com

Michael B Andersen, MD contact

004531254343

michael.brun.andersen@regionh.dk

Denmark2 sites, 2 recruiting
  • Copenhagen University Gentofte Hospital

    Copenhagen, Hellerup, 2900

    Liva J Spindler, MD

    Recruiting
  • Copenhagen University Hospital, Herlev Hospital

    Copenhagen, Herlev, 2400

    Louis L Plesner

    Recruiting

Other trials in Denmark

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 groups in NCT04859478
Study groupRoleWhat they receive
All eligible patientsOtherAll 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted26 Apr 2021
  2. Study start1 Jan 2021
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

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)
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

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.

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