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Completed

NCT Number: NCT05592444

Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection.

Effects on the level and homogeneity of contrast enhancement are measured and compared between groups.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

About this study

Spectral detector CT facilitates large reductions in contrast medium in vascular CT examinations. To our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose.

The purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in Computed Tomography Pulmonary Angiography (CTPA).

330 patients referred for clinically indicated CTPA are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. All patients receive the same amount of iodine (140 mg/kg).

Effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the CT images and the results are compared between groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of contrast dose (as calculated with the OmniVis calculator).
  • Patients with clinical suspicion of disease of PE
  • Referral to CTPA diagnosis, treatment planning or follow-up.
  • Peripheral venous catheter (PVC) =/< 18 G

Exclusion criteria

  • Contraindication to iodinated contrast medium
  • Age < 18 years
  • Lack of informed consent
  • Pregnancy

Treatment and study plan

Low iodine Spectral Detector CT Pulmonary Angiography

Diagnostic Test

Low iodine Spectral Detector CT Pulmonary Angiography

Primary outcomes

  1. Contrast enhancement (Vascular attenuation)

    Time frame: Measured on the CT images from the examination performed at enrollment

    Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination

Secondary outcomes

  1. Homogeneity of contrast enhancement (image noise)

    Time frame: Measured on the CT images from the examination performed at enrollment

    Homogeneity of contrast enhancement is measured as the standard deviation of attenuation in the pulmonary artery branches (equals image noise).

  2. Contrast to noise ratio (CNR)

    Time frame: Measured on the CT images from the examination performed at enrollment

    CNR is measured as (Vascular attenuation - Muscular attenuation) / Image noise

  3. Signal to noise ratio (SNR)

    Time frame: Measured on the CT images from the examination performed at enrollment

    SNR is measured as Vascular attenuation / Image noise

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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