Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations

NCT ID: NCT06965790

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-03-31

Brief Summary

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.

Conditions

CT Scans; Contrast Media; Gender; Womens Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

weight adjusted contrast media volume

control group with regular weight adjusted dosing

Group Type: NO_INTERVENTION

No interventions assigned to this group

blood volume adjusted contrast media volume

study group with dosing according to sex-specific blood volume

Group Type: ACTIVE_COMPARATOR

contrast media (Imeron 350, active ingredient Iomeprol) volume according to sex-specific blood volume

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Augsburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hosptial Augsburg

Augsburg, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Wollny, Dr.

Role: CONTACT

radiologie-studien@uk-augsburg.de

0049 (0) 821 400 ext. 2975

Facility Contacts

Josua Decker, PD MD

Role: primary

radiologie-studien@uk-augsburg.de

00498214002441

Other Identifiers

24040

Identifier Type: -

Identifier Source: org_study_id