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Venous Phase Dual Energy CT in Patients Suspected for Pulmonary Embolism.

Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859478
Enrollment
160
Registered
2021-04-26
Start date
2021-01-01
Completion date
2021-12-31
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolus/Emboli, Thromboembolism, Pulmonary

Keywords

CT, CTPA, Computed tomography, Computed tomography pulmonary angiography, Dual energy, Spectral, Sensitivity, Incidental findings, Iodine mapping, Radiology, Imaging, Diagnostic accuracy

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTDual energy / spectral portal venous chest computed tomography

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.

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients suspected for pulmonary embolism undergoing a computed tomography pulmonary angiography * Minimum age 50 years

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivitythrough study completion, approx. of 1 yearPer patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificitythrough study completion, approx. 1 yearPer patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA

Secondary

MeasureTime frameDescription
Sensitivitythrough study completion, approx. of 1 yearLobe and segment based sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificitythrough study completion, approx. of 1 yearLobe and segment based specificicty of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Incidental findingsthrough study completion, approx. of 1 yearEvaluation and management of incidental findings in portal venous phase chest CT compared to standard care CTPA.
Iodine mappingthrough study completion, approx. of 1 yearComparison of perfusion defects on iodine mapping between portal venous chest CT and CTPA. Descriptive.

Countries

Denmark

Contacts

Primary ContactYecatarina Zincuk Z Rohde, MD
katjazincuk@hotmail.com+4560222733
Backup ContactMichael B Andersen, MD
michael.brun.andersen@regionh.dk004531254343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026