Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography.

Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography. - InSPECT vs DECT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43477

Enrollment

375

Registered

2016-06-09

Start date

2016-07-07

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Pulmonary embolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients 35 years or older and able to provide informed consent - clinically requested CTPA because of suspected pulmonary embolism - available history and physical examination

Exclusion criteria

Exclusion criteria: - pregnancy - hemodynamic instability - uncooperative patients - contra-indication to intravenous iodine administration. - inability to position the arms above the shoulders

Design outcomes

Primary

Measure	Time frame
Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements. Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.	—

Measure

Time frame

Main endpoint of the study is presence of perfusion as established by an expert panel with access to all imaging information (including CTPA, subtraction and DECT) and clinical follow-up. Accuracy of DECT and subtraction is established by observers who are blinded to CTPA and clinical data. Presence of iodine density differences in perfusion defects is measured using region of interest (ROI) measurements. Images will be evaluated for objective and subjective image quality. Patient characteristics, radiation dose, clinical diagnosis, treatment decisions and patient outcome (all cause - and PE related mortality) will be recorded.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results