RadiationCOMpLExNCT03735706
Relationship Between Contrast Media Volume and Tube Voltage in CT for Optimal Liver Enhancement, Based on Body Weight.
A study testing Radiation dose reduction, Contrast media volume reduction and Unenhanced slice in people with Radiation and Contrast Media, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Computed Tomography (CT) is widely used in abdominal imaging for a variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. Attenuation of the liver makes it possible to recognize hypo- and hypervascular lesions, which are often invisible on unenhanced CT images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation, Contrast Media, Liver
- What is being tested?
- Radiation dose reduction, Contrast media volume reduction and Unenhanced slice
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2018to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for abdominal CT in portal venous phase
- Patients ≥ 18 years and competent to sign an informed consent
Who cannot join
- Hemodynamic instability
- Pregnancy
- Renal insufficiency (defined as Glomerular Filtration Rate (GFR) < 30 mL/min/1,73m2 [Odin protocol 004720])
- Iodine allergy (Odin protocol 022199)
- Age <18 years
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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]
Computed Tomography (CT) is widely used in abdominal imaging for a variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. Attenuation of the liver makes it possible to recognize hypo- and hypervascular lesions, which are often invisible on unenhanced CT images. Lesions can only be detected in case they are large enough and the contrast with the background is high enough. Heiken et al. showed already in 1995 that a difference in Hounsfield Units (HU) of at least 50 HU is needed to be able to recognize liver lesions [1]. On the other hand, patients should not receive more CM than necessarily, because of possible underlying physiological effects [2-4]. Although there has been some controversy about this recently, there is no need to give patients more CM than needed, because of increased costs, no quality improvement and their might still be a relationship with contrast induced nephropathy (CIN) [5].
Recent publications suggested individualization of injection protocols that can be based on either total body weight (TBW) or lean body weight (LBW) [6-9]. In the investigators department an injection protocol based on TBW is currently used.
Besides the CM injection parameters, scanner parameters are of influence on the attenuation as well. Because of recent technical developments it became possible to reach a good image quality (IQ) at lower tube voltages [10]. When the x-ray output comes closer to the 33 keV k-edge of Iodine, attenuation increases. In short, decreasing the tube voltage increases the attenuation of iodine. Scanning at a lower tube voltage therefore gives rise to even lower CM volumes. Lastly, it would be revolutionary to accomplish a liver enhancement that is homogenous, sufficient for lesion detection and comparable between patients and in the same patients, regardless of weight and scanner settings used.
Read the detailed description
Computed Tomography (CT) is a non-invasive imaging tool, used for a great variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. The visibility of liver lesions depends mainly on the ratio between the size and the difference of the lesion to the background. A large lesion might be visible without administration of CM, whilst a smaller lesion needs the addition of CM to become visible. Additionally, CM can be useful in the characterization of liver lesions. Heiken et al. (1995) found that an attenuation of the parenchyma after CM administration of at least ∆ 50 Hounsfield units (HU) compared to an unenhanced scan (in the same patient) is necessary to recognize liver lesions. This study proposed a dosing factor of 0.521 g I/kg to be necessary to reach such attenuation at a tube voltage of 120 kV [1].
The parenchymal enhancement depends on patient, CT scanner and CM factors. Weight, height, cardiac output, age, gender, venous access, breath-holding, renal function and comorbidity all fall under patient factors [8]. Recently much research showed preferable outcomes for individualized CM injection protocols, in which the contrast bolus is adapted to patient TBW, LBW or body surface area (BSA) [6, 7, 9, 13-15]. In a recent feasibility study in the department of the investigators, the attenuation of the liver parenchyma was evaluated. Results showed that a body weight adapted CM injection protocol resulted in more homogeneous liver enhancement compared to a fixed CM dose (not published yet).
With recent technological developments in X-ray tube technology it became possible to use lower tube voltages. As a result making it possible to perform scans with a sufficient image quality (IQ) and a low tube voltage and therefore a lower radiation dose [10]. Another advantage lies in the fact that reducing the tube voltage, approaching 33 keV k-edge of iodine, results in an increase in attenuation of the iodine. The new technological developments make it possible to reduce the radiation dose and CM volume at the same time. So reducing the tube voltage, makes it also possible to reduce the CM volume.
As recommended by the supplier, it is possible to calculate the total iodine load (TIL) that can be spared with the use of lower kV settings [16]. A reduction of 10 kV should result in a 10% reduction in CM volume. Reducing the tube voltage from 120 to 90 kV should therefore lead to a 30% reduction in CM volume. As mentioned before it is preferred to use an individualized CM injection protocol based on TBW or LBW. For this study, this theory is adapted to the concept of TBW. The following indicates which dosing factors should be used for each kV setting, based on the recommendations mentioned in the above.
120 kV -> 0.521 g I/kg 110 kV -> 0.469 g I/kg 100 kV -> 0.417 g I/kg 90 kV -> 0.365 g I/kg 80 kV -> 0.313 g I/kg 70 kV -> 0.261 g I/kg
The aim of present study is to investigate if adapting the dosing factor based on TBW and therefore the CM volume to the tube voltage used, results in a more homogeneous liver enhancement. The hypothesis is to find a more homogeneous enhancement between patients and in the same patient, regardless of body composition and tube voltage used.
- Conditions
- Radiation, Contrast Media, Liver, Body Weight
- Being tested
- Radiation dose reduction, Contrast media volume reduction, Unenhanced slice, Weight
- Keywords
- Radiation, Contrast media, Liver, Body Weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation dose reductionRadiation
The radiation dose is is different between groups
Contrast media volume reductionOther
Contrast media volume is different between groups
Unenhanced sliceRadiation
One unenhanced slice at the level of the portal vein will be added to the protocol before administration of contrast media. It will only take a minute to perform this extra slice. The patient does not have to visit the department a second time and no (extra) contrast is needed for this slice.
WeightDiagnostic test
A weighing scale is used to measure a patients body weight right before the scan.
| Study group | Role | What they receive |
|---|---|---|
| Control group - 120 kV - 0.521 g I/kg | Active comparator | Weight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed.
Contrast media injection protocol with a standard dosing factor of 0.521 g I/kg of TBW and a tube voltage of 120 kV.
The intervention is the application of a standard contrast media volume and a standard tube voltage of 120 kV. Receives: Radiation: Unenhanced slice; Diagnostic Test: Weight |
| 90 kV - 0.521 g I/kg | Experimental | Weight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed.
Contrast media injection protocol with a standard dosing factor of 0.521 g I/kg of TBW.
A radiation dose reduction from 120 to 90 kV.
The intervention is a change in tube voltage to 90 kV, compared to group 1. The other intervention; contrast media volume, is unchanged compared to group 1. Receives: Radiation: Radiation dose reduction; Radiation: Unenhanced slice; Diagnostic Test: Weight |
| 100 kV - 0.417 g I/kg | Experimental | Weight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed.
Contrast media volume reduction with a dosing factor of 0.417 g I/kg of TBW. A radiation dose reduction from 120 to 100 kV compared to group 1.
The intervention is a change in tube voltage to 100 kV, compared to group 1. The other intervention is a change in contrast media volume, which is adapted to the tube voltage used and therefore lowered to 0.417 g I/kg. Receives: Radiation: Radiation dose reduction; Other: Contrast media volume reduction; Radiation: Unenhanced slice; Diagnostic Test: Weight |
| 90 kV - 0.365 g I/kg | Experimental | Weight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed.
Contrast media volume reduction with a dosing factor of 0.365 g I/kg of TBW. A radiation dose reduction from 120 to 90 kV compared to group 1.
The intervention is a change in tube voltage to 90 kV, compared to group 1. The other intervention is a change in contrast media volume, which is adapted to the tube voltage used and therefore lowered to 0.365 g I/kg. Receives: Radiation: Radiation dose reduction; Other: Contrast media volume reduction; Radiation: Unenhanced slice; Diagnostic Test: Weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
A liver attenuation (Δ HU)
The attenuation of the liver parenchyma as assessed by measuring the Hounsfield units (HU) of the liver parenchyma in an unenhanced CT scan and a scan in portal venous phase. The difference between the enhanced and unenhanced CT scan is the Δ HU. It is expected that scans in all groups have a Δ HU of at least 50 HU, which is considered sufficient. Therefore it is a non-inferiority outcome.
Measured: Measurement for each scan is performed withing 1 month after the scan.
Secondary outcomes (14)
Objective image quality - signal-to-noise and contrast-to-noise ratio
The objective image quality parameters consist of signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR). SNR is calculated by dividing the attenuation of the liver parenchyma by the corresponding standard deviation (SD) of the attenuation. The attenuation of the left erector spinae muscle is measured at the level of the liver to calculate CNR using the following established formula: liver segment attenuation minus intramuscular attenuation, divided by the SD of the intramuscular attenuation. For both a higher number indicated a better image quality. The outcome should not be significantly different between groups.
Measured: Measurement for each scan is performed within 1 month after the scan.
Subjective image quality - assessed with a 5-point Likert scale
Two experienced radiologists will assess the subjective image quality in consensus, while being blinded for the protocol used. A 5-point Likert scale is used, in which 1= excellent; 2= good; 3 = moderate; 4 = poor; 5 = very poor. So a higher number is a worse outcome. The scale does not have a particular name.
Measured: Measurement for each scan is performed within 1 month after the scan.
Radiation dose
The mean effective mAs (± SD), mean CTDIvol (mGy) (± SD) and the Mean DLP (mGy*cm) (± SD) are visible on screen and reported, to compare the difference in radiation dose between groups. A higher number means a higher radiation dose and is therefore a worse outcome.
Measured: Measurement for each scan is performed within 1 month after the scan.
Weight
Patients weight (in kg) is assessed by using a weighting scale
Measured: Directly prior to the scan it is measured and data is collected within one month after the scan.
Height (in m)
Patients height is asked
Measured: Directly prior to the scan it is measured and data is collected within one month after the scan.
Contrast media volume
A dedicated data acquisition program (Certega Informatics Solution; Bayer) continuously monitors and collects all injection parameters (eg, total amount of CM [milliliter] and peak flow rate [milliliter per seconds]). A higher number means a higher radiation dose and is therefore a worse outcome. And results are compared between groups.
Measured: Data is retrieved from the system within 1 month after the scan.
Needle size
A dedicated data acquisition program (Certega Informatics Solution; Bayer) continuously monitors and collects all injection parameters, among which needle size is one of the parameters. A smaller gauge of the needle could possibly mean that the desired flow rate is not possible. In general it is expected that the needle size used is not significantly different between groups.
Measured: Data is retrieved from the system within 1 month after the scan. It is finished when all patients are scanned.
Needle placement
A dedicated data acquisition program (Certega Informatics Solution; Bayer) continuously monitors and collects all injection parameters, among which needle placement is one of the parameters. In general it is expected that the needle placement is not significantly different between groups.
Measured: Data is retrieved from the system within 1 month after the scan.
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Calculated after the scan, within 1 month after the scan.
Sex
Is collected
Measured: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Age
Is collected
Measured: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Scan indication
Is collected
Measured: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Flow rate
A dedicated data acquisition program (Certega Informatics Solution; Bayer) continuously monitors and collects peak flow rate [milliliter per seconds]).
Measured: Data is retrieved from the system within 1 month after the scan.
Concentration of the contrast media
All patients receive the identical contrast media concentration as used in daily clinical routine; 300 mg/ml
Measured: Data is retrieved from the system within 1 month after the scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start13 Dec 2018
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial with 4 study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Wildberger, Professor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735706
- Sponsor's protocol ID
- NL66971.068.18
- Acronym
- COMpLEx
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2018
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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]
- ClinicalTrials.gov ID
- NCT03735706
- Acronym / sponsor ID
- COMpLEx / NL66971.068.18
- Conditions
- Radiation, Contrast Media, Liver, Body Weight
- Keywords
- Radiation, Contrast media, Liver, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Computed Tomography (CT) is widely used in abdominal imaging for a variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. Attenuation of the liver makes it possible to recognize hypo- and hypervascular lesions, which are often invisible on unenhanced CT images. Lesions can only be detected in case they are large enough and the contrast with the background is high enough. Heiken et al. showed already in 1995 that a difference in Hounsfield Units (HU) of at least 50 HU is needed to be able to recognize liver lesions [1]. On the other hand, patients should not receive more CM than necessarily, because of possible underlying physiological effects [2-4]. Although there has been some controversy about this recently, there is no need to give patients more CM than needed, because of increased costs, no quality improvement and their might still be a relationship with contrast induced nephropathy (CIN) [5].
Recent publications suggested individualization of injection protocols that can be based on either total body weight (TBW) or lean body weight (LBW) [6-9]. In the investigators department an injection protocol based on TBW is currently used.
Besides the CM injection parameters, scanner parameters are of influence on the attenuation as well. Because of recent technical developments it became possible to reach a good image quality (IQ) at lower tube voltages [10]. When the x-ray output comes closer to the 33 keV k-edge of Iodine, attenuation increases. In short, decreasing the tube voltage increases the attenuation of iodine. Scanning at a lower tube voltage therefore gives rise to even lower CM volumes. Lastly, it would be revolutionary to accomplish a liver enhancement that is homogenous, sufficient for lesion detection and comparable between patients and in the same patients, regardless of weight and scanner settings used.
Detailed description
Computed Tomography (CT) is a non-invasive imaging tool, used for a great variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. The visibility of liver lesions depends mainly on the ratio between the size and the difference of the lesion to the background. A large lesion might be visible without administration of CM, whilst a smaller lesion needs the addition of CM to become visible. Additionally, CM can be useful in the characterization of liver lesions. Heiken et al. (1995) found that an attenuation of the parenchyma after CM administration of at least ∆ 50 Hounsfield units (HU) compared to an unenhanced scan (in the same patient) is necessary to recognize liver lesions. This study proposed a dosing factor of 0.521 g I/kg to be necessary to reach such attenuation at a tube voltage of 120 kV [1].
The parenchymal enhancement depends on patient, CT scanner and CM factors. Weight, height, cardiac output, age, gender, venous access, breath-holding, renal function and comorbidity all fall under patient factors [8]. Recently much research showed preferable outcomes for individualized CM injection protocols, in which the contrast bolus is adapted to patient TBW, LBW or body surface area (BSA) [6, 7, 9, 13-15]. In a recent feasibility study in the department of the investigators, the attenuation of the liver parenchyma was evaluated. Results showed that a body weight adapted CM injection protocol resulted in more homogeneous liver enhancement compared to a fixed CM dose (not published yet).
With recent technological developments in X-ray tube technology it became possible to use lower tube voltages. As a result making it possible to perform scans with a sufficient image quality (IQ) and a low tube voltage and therefore a lower radiation dose [10]. Another advantage lies in the fact that reducing the tube voltage, approaching 33 keV k-edge of iodine, results in an increase in attenuation of the iodine. The new technological developments make it possible to reduce the radiation dose and CM volume at the same time. So reducing the tube voltage, makes it also possible to reduce the CM volume.
As recommended by the supplier, it is possible to calculate the total iodine load (TIL) that can be spared with the use of lower kV settings [16]. A reduction of 10 kV should result in a 10% reduction in CM volume. Reducing the tube voltage from 120 to 90 kV should therefore lead to a 30% reduction in CM volume. As mentioned before it is preferred to use an individualized CM injection protocol based on TBW or LBW. For this study, this theory is adapted to the concept of TBW. The following indicates which dosing factors should be used for each kV setting, based on the recommendations mentioned in the above.
120 kV -> 0.521 g I/kg 110 kV -> 0.469 g I/kg 100 kV -> 0.417 g I/kg 90 kV -> 0.365 g I/kg 80 kV -> 0.313 g I/kg 70 kV -> 0.261 g I/kg
The aim of present study is to investigate if adapting the dosing factor based on TBW and therefore the CM volume to the tube voltage used, results in a more homogeneous liver enhancement. The hypothesis is to find a more homogeneous enhancement between patients and in the same patient, regardless of body composition and tube voltage used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- randomized controlled trial with 4 study arms.
| Arm | Type | Receives |
|---|---|---|
| Control group - 120 kV - 0.521 g I/kg | Active comparator | Radiation: Unenhanced slice, Diagnostic Test: WeightWeight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed. Contrast media injection protocol with a standard dosing factor of 0.521 g I/kg of TBW and a tube voltage of 120 kV. The intervention is the application of a standard contrast media volume and a standard tube voltage of 120 kV. |
| 90 kV - 0.521 g I/kg | Experimental | Radiation: Radiation dose reduction, Radiation: Unenhanced slice, Diagnostic Test: WeightWeight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed. Contrast media injection protocol with a standard dosing factor of 0.521 g I/kg of TBW. A radiation dose reduction from 120 to 90 kV. The intervention is a change in tube voltage to 90 kV, compared to group 1. The other intervention; contrast media volume, is unchanged compared to group 1. |
| 100 kV - 0.417 g I/kg | Experimental | Radiation: Radiation dose reduction, Other: Contrast media volume reduction, Radiation: Unenhanced slice, Diagnostic Test: WeightWeight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed. Contrast media volume reduction with a dosing factor of 0.417 g I/kg of TBW. A radiation dose reduction from 120 to 100 kV compared to group 1. The intervention is a change in tube voltage to 100 kV, compared to group 1. The other intervention is a change in contrast media volume, which is adapted to the tube voltage used and therefore lowered to 0.417 g I/kg. |
| 90 kV - 0.365 g I/kg | Experimental | Radiation: Radiation dose reduction, Other: Contrast media volume reduction, Radiation: Unenhanced slice, Diagnostic Test: WeightWeight is measured prior to the scan. Before performing the contrast enhanced CT scan(s), an unenhanced slice through the liver, at the level of the portal vein, is performed. Contrast media volume reduction with a dosing factor of 0.365 g I/kg of TBW. A radiation dose reduction from 120 to 90 kV compared to group 1. The intervention is a change in tube voltage to 90 kV, compared to group 1. The other intervention is a change in contrast media volume, which is adapted to the tube voltage used and therefore lowered to 0.365 g I/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for abdominal CT in portal venous phase
- Patients ≥ 18 years and competent to sign an informed consent
Key exclusion criteria (6 listed)
- Hemodynamic instability
- Pregnancy
- Renal insufficiency (defined as Glomerular Filtration Rate (GFR) < 30 mL/min/1,73m2 [Odin protocol 004720])
- Iodine allergy (Odin protocol 022199)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation dose reductionThe radiation dose is is different between groups | Radiation | 100 kV - 0.417 g I/kg, 90 kV - 0.365 g I/kg, 90 kV - 0.521 g I/kg |
| Contrast media volume reductionContrast media volume is different between groups | Other | 100 kV - 0.417 g I/kg, 90 kV - 0.365 g I/kg |
| Unenhanced sliceOne unenhanced slice at the level of the portal vein will be added to the protocol before administration of contrast media. It will only take a minute to perform this extra slice. The patient does not have to visit the department a second time and no (extra) contrast is needed for this slice. | Radiation | 100 kV - 0.417 g I/kg, 90 kV - 0.365 g I/kg, 90 kV - 0.521 g I/kg, Control group - 120 kV - 0.521 g I/kg |
| WeightA weighing scale is used to measure a patients body weight right before the scan. | Diagnostic test | 100 kV - 0.417 g I/kg, 90 kV - 0.365 g I/kg, 90 kV - 0.521 g I/kg, Control group - 120 kV - 0.521 g I/kg |
Primary outcome
A liver attenuation (Δ HU)
Time frame: Measurement for each scan is performed withing 1 month after the scan.
The attenuation of the liver parenchyma as assessed by measuring the Hounsfield units (HU) of the liver parenchyma in an unenhanced CT scan and a scan in portal venous phase. The difference between the enhanced and unenhanced CT scan is the Δ HU. It is expected that scans in all groups have a Δ HU of at least 50 HU, which is considered sufficient. Therefore it is a non-inferiority outcome.
14 secondary outcomes
Objective image quality - signal-to-noise and contrast-to-noise ratio
Time frame: Measurement for each scan is performed within 1 month after the scan.
Subjective image quality - assessed with a 5-point Likert scale
Time frame: Measurement for each scan is performed within 1 month after the scan.
Radiation dose
Time frame: Measurement for each scan is performed within 1 month after the scan.
Weight
Time frame: Directly prior to the scan it is measured and data is collected within one month after the scan.
Height (in m)
Time frame: Directly prior to the scan it is measured and data is collected within one month after the scan.
Contrast media volume
Time frame: Data is retrieved from the system within 1 month after the scan.
Needle size
Time frame: Data is retrieved from the system within 1 month after the scan. It is finished when all patients are scanned.
Needle placement
Time frame: Data is retrieved from the system within 1 month after the scan.
BMI
Time frame: Calculated after the scan, within 1 month after the scan.
Sex
Time frame: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Age
Time frame: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Scan indication
Time frame: Collected before the scan by the technician and retrieved from the system within 1 month after the scan.
Flow rate
Time frame: Data is retrieved from the system within 1 month after the scan.
Concentration of the contrast media
Time frame: Data is retrieved from the system within 1 month after the scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Wildberger, Professor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation dose reduction, Contrast media volume reduction and Unenhanced slice in people with Radiation and Contrast Media, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A liver attenuation (Δ HU) (time frame: Measurement for each scan is performed withing 1 month after the scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.