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

NCT06965790 | Recruiting

• 1 other identifier: 24040
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 1.control group with regular weight-adjusted (n = 200)
2. 2.study group with dosing according to blood volume (n = 200).

Conditions

Contrast Media; Gender; Womens Health; CT Scans

Keywords

CT; CT Scans; Contrast Media; contrast; gender

Outcome Measures

Primary Outcomes (2)

• Sex-specific contrast difference in the vessels and organs

  Achieved iodine contrast (Hounsfield units) in vessels and organs

  1 year

• Contrasting the organs after adjusting the application dose of the contrast agent to the specific blood volume

  Achieved iodine contrast (Hounsfield units) in vessels and organs

  1 year

Secondary Outcomes (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

  1 year

• Evaluation of the contrast values achieved that still allow sufficient assessment of the vessels and organs.

  1 year

• Comparison of the diagnostic accuracy of DECT/MECT-based imaging of vascular and organ structures.

  1 year

Study Arms (2)

weight adjusted contrast media volume

NO INTERVENTION

control group with regular weight adjusted dosing

blood volume adjusted contrast media volume

ACTIVE COMPARATOR

study group with dosing according to sex-specific blood volume

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

Interventions

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

blood volume adjusted contrast media volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hosptial Augsburg

Augsburg, Bavaria, 86157, Germany

RECRUITING

MeSH Terms

Conditions

Coitus

Interventions

Contrast Media

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Claudia Wollny, Dr.

CONTACT

0049 (0) 821 400; radiologie-studien@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)