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

Primary Purpose

Pulmonary Embolus/Emboli, Thromboembolism, Pulmonary

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dual energy / spectral portal venous chest computed tomography
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolus/Emboli focused on measuring CT, CTPA, Computed tomography, Computed tomography pulmonary angiography, Dual energy, Spectral, Sensitivity, Incidental findings, Iodine mapping, Radiology, Imaging, Diagnostic accuracy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Copenhagen University Gentofte HospitalRecruiting
  • Copenhagen University Hospital, Herlev HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All eligible patients

Arm Description

All patients undergo the same CT protocol in addition to standard care.

Outcomes

Primary Outcome Measures

Sensitivity
Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificity
Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA

Secondary Outcome Measures

Sensitivity
Lobe and segment based sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Specificity
Lobe and segment based specificicty of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Incidental findings
Evaluation and management of incidental findings in portal venous phase chest CT compared to standard care CTPA.
Iodine mapping
Comparison of perfusion defects on iodine mapping between portal venous chest CT and CTPA. Descriptive.

Full Information

First Posted
April 20, 2021
Last Updated
April 22, 2021
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT04859478
Brief Title
Venous Phase Dual Energy CT in Patients Suspected for Pulmonary Embolism.
Official Title
Venous Phade Dual Energy Computed Tomography in Patients Suspected for Pulmonary Embolism: Diagnostic Accuracy and Evaluation of Incidental Findings.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All eligible patients
Arm Type
Other
Arm Description
All patients undergo the same CT protocol in addition to standard care.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual energy / spectral portal venous chest computed tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Per patient sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Time Frame
through study completion, approx. of 1 year
Title
Specificity
Description
Per patient specificity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Time Frame
through study completion, approx. 1 year
Secondary Outcome Measure Information:
Title
Sensitivity
Description
Lobe and segment based sensitivity of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Time Frame
through study completion, approx. of 1 year
Title
Specificity
Description
Lobe and segment based specificicty of portal venous phase chest DECT in diagnosing PE compared to the corresponding reference CTPA
Time Frame
through study completion, approx. of 1 year
Title
Incidental findings
Description
Evaluation and management of incidental findings in portal venous phase chest CT compared to standard care CTPA.
Time Frame
through study completion, approx. of 1 year
Title
Iodine mapping
Description
Comparison of perfusion defects on iodine mapping between portal venous chest CT and CTPA. Descriptive.
Time Frame
through study completion, approx. of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yecatarina Zincuk Z Rohde, MD
Phone
+4560222733
Email
katjazincuk@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael B Andersen, MD
Phone
004531254343
Email
michael.brun.andersen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yecatarina Z Rohde, MD
Organizational Affiliation
Copenhagen University Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Gentofte Hospital
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liva J Spindler, MD
Facility Name
Copenhagen University Hospital, Herlev Hospital
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis L Plesner

12. IPD Sharing Statement

Plan to Share IPD
No

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

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