Clinical trial NCT05592444: Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography
Official title: Different Strategies to Reduce Contrast Medium in Computed Tomography Pulmonary Angiography Using Spectral Detector CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Spectral Detector CT
Contrast medium
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly assigned to one of three injection methods: low concentration, low-volume and saline-dilution.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast enhancement (Vascular attenuation)
timeFrame: Measured on the CT images from the examination performed at enrollment
Secondary outcomes:
measure: Homogeneity of contrast enhancement (image noise)
timeFrame: Measured on the CT images from the examination performed at enrollment
measure: Contrast to noise ratio (CNR)
timeFrame: Measured on the CT images from the examination performed at enrollment
measure: Signal to noise ratio (SNR)
timeFrame: Measured on the CT images from the examination performed at enrollment
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Viken
Study officials:
affiliation: University Hospital, Akershus
name: Peter M Lauritzen, PhD
role: PRINCIPAL_INVESTIGATOR
References: