Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

NCT05592444 | Completed

• 1 other identifier: 142126
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Spectral Detector CT; Contrast medium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Homogeneity of contrast enhancement (image noise)

  Measured on the CT images from the examination performed at enrollment

• Contrast to noise ratio (CNR)

  Measured on the CT images from the examination performed at enrollment

• Signal to noise ratio (SNR)

  Measured on the CT images from the examination performed at enrollment

Study Arms (3)

Low concentration

EXPERIMENTAL

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 volume

EXPERIMENTAL

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

Saline Dilution

EXPERIMENTAL

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

Interventions

Low iodine Spectral Detector CT Pulmonary Angiography DIAGNOSTIC_TEST

Low iodine Spectral Detector CT Pulmonary Angiography

Low concentration; Low volume; Saline Dilution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter M Lauritzen, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Acquired CT images are identical for all participants. The study arm is unknown to all, except the radiographers (radiology technicians) performing the examination.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: November 23, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)