Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05592444
• Other study ID #: 142126
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: April 2024
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Low iodine Spectral Detector CT Pulmonary Angiography
Low iodine Spectral Detector CT Pulmonary Angiography

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Viken

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast enhancement (Vascular attenuation)	Contrast enhancement measured as attenuation in the pulmonary artery Branches on the acquired CTPA examination	Measured on the CT images from the examination performed at enrollment
Secondary	Homogeneity of contrast enhancement (image noise)	Homogeneity of contrast enhancement is measured as the standard deviation of attenuation in the pulmonary artery branches (equals image noise).	Measured on the CT images from the examination performed at enrollment
Secondary	Contrast to noise ratio (CNR)	CNR is measured as (Vascular attenuation - Muscular attenuation) / Image noise	Measured on the CT images from the examination performed at enrollment
Secondary	Signal to noise ratio (SNR)	SNR is measured as Vascular attenuation / Image noise	Measured on the CT images from the examination performed at enrollment