Sex-specific individualized contrast dosing for chest and abdominal CT scans

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Augsburg (other)
• Locations: 1 site (Augsburg, Bavaria)
• Trial ID: NCT06965790 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Augsburg, Bavaria

• University Hosptial Augsburg — Augsburg, Bavaria, Germany (RECRUITING)

Study contacts

• Study coordinator: Claudia Wollny, Dr.

Conditions: CT Scans, Contrast Media, Gender, Womens Health, CT, contrast, gender