Actively Recruiting
Randomized Controlled Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations to Achieve Equal Contrast in Men and Women
Led by University Hospital Augsburg · Updated on 2025-12-09
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how to improve the dosing of iodine-containing contrast media used in CT scans of the thorax and abdomen, focusing on differences between men and women. Current dosing is based on body weight, but previous research showed women tend to have about 10% higher iodine contrast compared to men of the same height and weight, likely due to physiological sex differences in blood volume. The study aims to test whether adjusting contrast doses based on blood volume rather than weight can equalize contrast levels between sexes. Participants will be randomly assigned to one of two groups: a control group receiving the usual weight-based contrast dose, and a study group receiving a contrast dose adjusted by sex-specific blood volume using the Nadler formula. The contrast agent used is Imeron 350 containing Iomeprol, with adjustments made by replacing saved contrast volume with saline. The study will compare iodine contrast values in vessels and organs between these groups. During the study, participants will undergo a contrast-enhanced CT scan in the portal venous phase. The team will measure the sex-specific differences in contrast and evaluate whether blood volume-based dosing provides sufficient contrast for diagnostic purposes. Secondary assessments include verifying the adequacy of adjusted contrast amounts and comparing imaging accuracy using dual- or multi-energy CT. The study will last for one year, with all imaging and evaluations done under medical supervision.
CONDITIONS
Brief Title
Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Justified indication for a CT scan of the chest and abdomen with intravenous contrast in the portal venous phase
- Ability to give informed consent, including written and verbal agreement to participate
You will not qualify if you...
- Cardiorespiratory instability as judged by the attending physician
- Age under 18 years
- Known or suspected pregnancy
- Previous liver surgery or spleen removal
- Missing or unable to measure current height during the same hospital visit
- Missing or unable to measure current body weight
- Height under 140 cm or over 220 cm
- Body weight under 50 kg or over 120 kg
- Allergy to iodine-containing contrast media
- Severe kidney failure (eGFR below 30 ml/min)
- Hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants receive a CT scan of the chest and abdomen with intravenous contrast agent dosed either by regular weight adjustment or sex-specific blood volume adjustment.
1 visit (in-person)
Duration - 1 year
Participants are monitored for contrast effectiveness and diagnostic accuracy in vessels and organs over one year after the CT scan.
Trial Site Locations
Total: 1 location
1
University Hosptial Augsburg
Augsburg, Bavaria, Germany, 86157
Actively Recruiting
Research Team
C
Claudia Wollny, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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