Strategies to Reduce Contrast Medium in Spectral CT Pulmonary Angiography

University Hospital, Akershus

Status: Completed

Conditions: Pulmonary Embolism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05592444

142126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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330 participants in 3 patient groups

Low concentration

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography

Low volume

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography

Saline Dilution

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Low iodine Spectral Detector CT Pulmonary Angiography