The relationship between contrast media volume and tube voltage in computed tomography of the liver, for optimal enhancement based on total body weight: A randomized controlled trial. [COMpLEx trial]

The relationship between contrast media volume and tube voltage in computed tomography of the liver, for optimal enhancement based on total body weight: A randomized controlled trial. [COMpLEx trial] - Body weight, CM volume and kV in liver CT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46148

Enrollment

256

Registered

2018-11-29

Start date

2018-12-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver lesions

Interventions

NVT

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients referred for abdominal CT Patients older than 18 years and competent to sign an informed consent

Exclusion criteria

Exclusion criteria: Hemodynamic instability Pregnancy Renal insufficiency (defined as Glomerular Filtration Rate (GFR)

Design outcomes

Primary

Measure	Time frame
To evaluate the possibilities to reduce radiation dose and CM volume in patients receiving an abdominal CT scan. All scans performed in portal venous phase and with or without an unenhanced and/or arterial and/or delayed scan are included. A scan is defined diagnostic as an attenuation increase of >= 50 HU between the unenhanced and the portal venous phase scan is achieved. We hypothesise that in abdominal CT the tube voltage and therefore CM volume can be reduced with a sufficient liver enhancement of >= 50 HU.	—

Measure

Time frame

To evaluate the possibilities to reduce radiation dose and CM volume in patients receiving an abdominal CT scan. All scans performed in portal venous phase and with or without an unenhanced and/or arterial and/or delayed scan are included. A scan is defined diagnostic as an attenuation increase of >= 50 HU between the unenhanced and the portal venous phase scan is achieved. We hypothesise that in abdominal CT the tube voltage and therefore CM volume can be reduced with a sufficient liver enhancement of >= 50 HU.

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Secondary

Measure	Time frame
To evaluate the objective IQ (liver attenuation [HU], image noise, SNR and CNR) in the various groups. SNR is calculated with the following formula: Attenuation of the liver parenchyma ------------------------------------------------------- Standard deviation (SD) of the liver parenchyma attenuation The CNR will be calculated accordingly: Liver segment attenuation - Intramuscular ------------------------------------------------------------- SD of the intramuscular attenuation The subjective IQ in the four groups will be determined with the use of a 5-point Likert scale [1 = excellent; 2 = good; 3 = moderate; 4 = poor; 5 = very poor] (43). The dose report form, as visible on our PACS workstation (IMPAX verse 6.6.1. 5003, AGFA HealthCare N.V., Mortsel, Belgium), will be used to subtract the radiation dose. The values for the portal venous phase scan of the total abdomen will be used to compare the radiation dose between scans.	—

Measure

Time frame

To evaluate the objective IQ (liver attenuation [HU], image noise, SNR and CNR) in the various groups. SNR is calculated with the following formula: Attenuation of the liver parenchyma ------------------------------------------------------- Standard deviation (SD) of the liver parenchyma attenuation The CNR will be calculated accordingly: Liver segment attenuation - Intramuscular ------------------------------------------------------------- SD of the intramuscular attenuation The subjective IQ in the four groups will be determined with the use of a 5-point Likert scale [1 = excellent; 2 = good; 3 = moderate; 4 = poor; 5 = very poor] (43). The dose report form, as visible on our PACS workstation (IMPAX verse 6.6.1. 5003, AGFA HealthCare N.V., Mortsel, Belgium), will be used to subtract the radiation dose. The values for the portal venous phase scan of the total abdomen will be used to compare the radiation dose between scans.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)