Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations
Randomized Controlled Study on Sex-specific, Individualized Dose Calculation of Intravenously Administered Contrast Agent in CT Examinations in Portal Venous Phase to Achieve Equivalent Contrast in Men and Women
A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. 0.2-0.4 g iodine/kg body weight), but a standardized application dose of the contrast agent is often also used.
In earlier studies, the investigators found that the iodine contrast in vessels and organs achieved with a standardized amount of contrast agent differs significantly between women and men. On average, women showed around 10% higher iodine contrast than men of the same height and weight. The investigators attribute these differences to physiological, sex-specific differences in blood volume. For example, the blood volume of a woman 175 cm tall and weighing 75 kg is approx. 400 ml less than that of a man of the same height and weight (approx. 4.6 vs. 5.0 l, calculated according to Nadler). Taking blood volume into account, sex was no longer a significant influencing factor in a retrospective cohort (n=274).
The investigators would now like to investigate these results in a prospective study. For this purpose, two groups of patients with a clinical indication for a contrast-enhanced CT scan in the venous phase will be compared:
- control group with regular weight-adjusted (n = 200)
- study group with dosing according to blood volume (n = 200).
The hypothesis is that the application scheme adapted to the blood volume leads to a more homogeneous contrasting of women and men. In order to quantify this effect, the iodine contrast values of both groups will be quantitatively analyzed, taking into account other influencing variables (height, weight).
The investigators hope that this approach will reduce or even eliminate the observed sex-specific differences. This would lead to a sex-equal contrast based on an individualized amount of contrast medium.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claudia Wollny, Dr.
- Phone Number: 2975 0049 (0) 821 400
- Email: radiologie-studien@uk-augsburg.de
Study Locations
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Bavaria
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Augsburg, Bavaria, Germany, 86157
- Recruiting
- University Hosptial Augsburg
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Contact:
- Josua Decker, PD MD
- Phone Number: 00498214002441
- Email: radiologie-studien@uk-augsburg.de
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of a justifying indication for a CT scan of the thorax and abdomen with application of intravenous contrast medium and a start delay corresponding to the portal venous contrast medium phase
- Ability to give informed consent, as well as written and verbal consent to participate in the study available
Exclusion Criteria:
- Cardiorespiratory instability (as assessed by the attending physician)
- Age <18 years
- Existing or suspected pregnancy
- Known post hepatectomy and/or splenectomy
- Lack of current height (in the same inpatient/outpatient hospital stay) or lack of possibility of height measurement
- Lack of current daily body weight or inability to measure body weight
- Height under 140 cm or over 220 cm
- Body weight under 50 kg or over 120 kg
- Contraindication to iodine-containing contrast medium (Allergy to contrast media containing iodine, Severe renal insufficiency (eGFR < 30 ml/min), Hyperthyroidism)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: weight adjusted contrast media volume
control group with regular weight adjusted dosing
|
|
|
Active Comparator: blood volume adjusted contrast media volume
study group with dosing according to sex-specific blood volume
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Calculation of the standardized contrast agent (Imeron 350, active ingredient Iomeprol) quantity (0.35 g iodine/kg) and calculation of the specific blood volume using the established Nadler formula for male and female.
Adjustment of the contrast agent according to the ratio of the blood volumes.
The amount of saved contrast agent is replaced 1:1 by NaCl.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex-specific contrast difference in the vessels and organs
Time Frame: 1 year
|
Achieved iodine contrast (Hounsfield units) in vessels and organs
|
1 year
|
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Contrasting the organs after adjusting the application dose of the contrast agent to the specific blood volume
Time Frame: 1 year
|
Achieved iodine contrast (Hounsfield units) in vessels and organs
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of whether the adapted blood volume formula according to Nadler can be used to achieve the minimum amount of contrast medium required to ensure sufficient contrast
Time Frame: 1 year
|
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series.
Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series.
The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
|
1 year
|
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Evaluation of the contrast values achieved that still allow sufficient assessment of the vessels and organs.
Time Frame: 1 year
|
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series.
Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series.
The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
|
1 year
|
|
Comparison of the diagnostic accuracy of DECT/MECT-based imaging of vascular and organ structures.
Time Frame: 1 year
|
Quantitative measurements of the attenuation of the liver, the portal vein, the aorta, the spleen and the kidneys by placing circular ROIs on CT-series.
Mean and standard deviation of CT-values are obtained from contrast enhanced series, iodine maps and virtual non-contrast series.
The measurements are performed by blinded physicians using anonymized data on a dedicated workstation.
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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