Sex-specific individualized contrast dosing for chest and abdominal CT scans
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
Run by University Hospital Augsburg · NCT06965790 · Data updated 2026-11-12
This study tests whether calculating iodine contrast dose from sex-specific blood volume gives more consistent CT image contrast for adults having chest and abdominal scans.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University Hospital Augsburg Academic / other |
| Locations | 1 site (Augsburg, Bavaria) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | March 2026 |
| Study ends | March 2027 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT06965790 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 and older) who need a CT scan of the chest and abdomen with intravenous iodine contrast, can give informed consent, and meet the study's height and weight limits are ideal candidates.
✕Probably not a fit
Patients with allergy to iodinated contrast, severe renal impairment, pregnancy, prior hepatectomy or splenectomy, unstable cardiorespiratory status, or height/weight outside the study range are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adults scheduled for contrast-enhanced CT of the thorax and abdomen and administers the iodinated agent Iomeprol with a dose calculated from sex-specific estimated blood volume. The dosing algorithm uses sex-based blood-volume estimates (for example Nadler formulas) rather than a single standardized or only weight-based amount. Portal venous phase images will be obtained and contrast enhancement in vessels and organs will be measured and compared to typical dosing expectations to see if sex-specific dosing reduces variation. People with contraindications to iodinated contrast, pregnancy, extreme body sizes, or prior hepatectomy/splenectomy are excluded.
Why it matters
Potential benefit: If successful, this approach could provide more consistent image contrast between men and women and may allow more appropriate (and potentially lower) contrast doses for some patients.
How similar studies have gone: Earlier smaller studies have shown that women often have about 10% higher iodine enhancement than men of similar size, and this trial prospectively applies a novel sex-specific dosing approach based on that finding.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
University Hosptial Augsburg
Augsburg, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Claudia Wollny, Dr.
- Email: radiologie-studien@uk-augsburg.de
- Phone: 0049 (0) 821 400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.