Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-10-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomly assigned to one of three injection methods: low concentration, low-volume and saline-dilution.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Acquired CT images are identical for all participants. The study arm is unknown to all, except the radiographers (radiology technicians) performing the examination.

Study Groups

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Low concentration

Patients receive a contrast medium with an iodine concentration of 140 mg/ml. The volume is 1 ml/kg which result in a dose of 140 mg/kg.

Maximal dose of contrast medium is 90 ml i.e. 12.6 g of iodine.

Group Type EXPERIMENTAL

Low iodine Spectral Detector CT Pulmonary Angiography

Intervention Type DIAGNOSTIC_TEST

Low iodine Spectral Detector CT Pulmonary Angiography

Low volume

Patients receive a contrast medium with an iodine concentration 350 of mg/ml. The volume is 0.4 ml/kg which result in a dose of 140 mg/kg.

Maximal dose of contrast medium is 36 ml i.e. 12.6 g of iodine.

Group Type EXPERIMENTAL

Low iodine Spectral Detector CT Pulmonary Angiography

Intervention Type DIAGNOSTIC_TEST

Low iodine Spectral Detector CT Pulmonary Angiography

Saline Dilution

Patients receive a contrast medium with an iodine concentration of 350 mg/ml. The contrast medium is diluted 1:1 with saline.

The injected volume is 0.8 ml/kg which result in a dose of 140 mg/kg. Maximal dose of contrast medium is 72 ml i.e. 12.6 g of iodine.

Group Type EXPERIMENTAL

Low iodine Spectral Detector CT Pulmonary Angiography

Intervention Type DIAGNOSTIC_TEST

Low iodine Spectral Detector CT Pulmonary Angiography

Interventions

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Low iodine Spectral Detector CT Pulmonary Angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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