Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume.
- Who it may be relevant to
- Registry conditions: CT Scans, Contrast Media, Gender, Womens Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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: 1. control group with regular weight-adjusted (n = 200) 2. 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.
Interventions
- Drug contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume
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.
Primary outcome measures
- Sex-specific contrast difference in the vessels and organs [Time frame: 1 year]
- Contrasting the organs after adjusting the application dose of the contrast agent to the specific blood volume [Time frame: 1 year]
Secondary outcome measures (3)
- 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]
- Evaluation of the contrast values achieved that still allow sufficient assessment of the vessels and organs. [Time frame: 1 year]
- Comparison of the diagnostic accuracy of DECT/MECT-based imaging of vascular and organ structures. [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Germany · 1 center
- University Hosptial Augsburg — Augsburg
Identifiers
NCT: NCT06965790 · 24040