Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

April 15, 2024 updated by: Peter Maehre Lauritzen, University Hospital, Akershus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Viken
      • Lørenskog, Viken, Norway, 1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Low iodine Spectral Detector CT Pulmonary Angiography
Low iodine Spectral Detector CT Pulmonary Angiography
Experimental: 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.
Diagnostic test: Low iodine Spectral Detector CT Pulmonary Angiography
Low iodine Spectral Detector CT Pulmonary Angiography
Experimental: 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.
Diagnostic test: Low iodine Spectral Detector CT Pulmonary Angiography
Low iodine Spectral Detector CT Pulmonary Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured on the CT images from the examination performed at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measured on the CT images from the examination performed at enrollment
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
Measured on the CT images from the examination performed at enrollment
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
Measured on the CT images from the examination performed at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Investigators

  • Principal Investigator: Peter M Lauritzen, PhD, University Hospital, Akershus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Actual)

October 12, 2021

Study Completion (Actual)

October 12, 2021

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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