NCT04859478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

April 20, 2021

Last Update Submit

April 22, 2021

Conditions

Pulmonary Embolus/EmboliThromboembolism, Pulmonary

Keywords

CTCTPAComputed tomographyComputed tomography pulmonary angiographyDual energySpectralSensitivityIncidental findingsIodine mappingRadiologyImagingDiagnostic accuracy

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

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

    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

    through study completion, approx. 1 year

Secondary Outcomes (4)

  • Sensitivity

    through study completion, approx. of 1 year

  • Specificity

    through study completion, approx. of 1 year

  • Incidental findings

    through study completion, approx. of 1 year

  • Iodine mapping

    through study completion, approx. of 1 year

Study Arms (1)

All eligible patients

OTHER

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

Diagnostic Test: Dual energy / spectral portal venous chest computed tomography

Interventions

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.

All eligible patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Copenhagen University Gentofte Hospital

Copenhagen, Hellerup, 2900, Denmark

RECRUITING

Copenhagen University Hospital, Herlev Hospital

Copenhagen, Herlev, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary EmbolismEmbolismHypersensitivity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesImmune System Diseases

Study Officials

  • Yecatarina Z Rohde, MD

    Copenhagen University Herlev Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yecatarina Zincuk Z Rohde, MD

CONTACT

+4560222733katjazincuk@hotmail.com

Michael B Andersen, MD

CONTACT

004531254343michael.brun.andersen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 26, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)