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

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.

Start Date15 May 2025

Sponsor / Collaborator

Universitatsklinikum Augsburg

CTIS2024-513251-32-00

/ Not yet recruitingPhase 4IIT

Role of contrast enhanced mammography with Iomeprol 400 mgI/ml (Iomeron, Bracco), in the identification of breast cancer: I3-MaC Study

Start Date02 May 2024

Sponsor / Collaborator-

NCT02596048

/ CompletedPhase 4

A Phase IV Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) of the Thoraco-Abdominal Aorta, and the Carotid, Pulmonary, and Peripheral Arteries

This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.

Start Date01 Dec 2015

Sponsor / Collaborator

Bracco Diagnostics, Inc.

[+2]

100 Clinical Results associated with Iomeprol

100 Translational Medicine associated with Iomeprol

100 Patents (Medical) associated with Iomeprol

691

Literatures (Medical) associated with Iomeprol

01 Nov 2025·CANADIAN ASSOCIATION OF RADIOLOGISTS JOURNAL-JOURNAL DE L ASSOCIATION CANADIENNE DES RADIOLOGISTES

Deep Learning-Based Contrast Boosting in Low-Contrast Media Pre-TAVR CT Imaging

Article

Author: Han, Kyunghwa ; Chang, Suyon ; Park, Jeaneun ; Jung, Jung Im

Purpose: This study investigates the impact of deep learning-based contrast boosting (DL-CB) on image quality and measurement reliability in low-contrast media (low-CM) CT for pre-transcatheter aortic valve replacement (TAVR) assessment. Methods: This retrospective study included TAVR candidates with renal dysfunction who underwent low-CM (30-mL: 15-mL bolus of contrast followed by 50-mL of 30% iomeprol solution) pre-TAVR CT between April and December 2023, along with matched standard-CM controls (n = 68). Low-CM images were reconstructed as conventional, 50-keV, and DL-CB images. Qualitative and quantitative image quality were compared among image sets. The aortic annulus was measured by 2 independent readers on low-CM CT images, and interobserver reliability was assessed. Results: DL-CB significantly improved contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR) compared to conventional and 50-keV images (CNR: 12.5-13.4, 18-19.8, and 21.9-24; SNR: 10.8-15.5, 10.7-15.5, and 16.8-26.7 on conventional, 50-keV, and DL-CB images, respectively; P < .001). DL-CB achieved comparable CNR (21.9-24 vs 27-27.7, P = .39-.61) and comparable to slightly higher SNR (16.8-26.7 vs 15.7-20.2, P = .003-.80) to standard-CM images. For aortic annular measurement, DL-CB demonstrated high interobserver reliability, with an intraclass correlation coefficient (ICC) of .96 and small mean differences (area: 0.01 cm², limits of agreement [LoA]: −0.52 to 0.55 cm²; perimeter: 0.02 mm, LoA: −4.49 to 4.53 mm). Conclusions: DL-CB improves image quality and provides high measurement reliability in low-CM CT for pre-TAVR assessment in patients with renal dysfunction, without requiring dual-energy CT.

31 Oct 2025·FASEB JOURNAL

Megalin‐Mediated Direct and Indirect Pathways for the Development of Contrast‐Induced Proximal Tubule Epithelial Cell Injury

Article

Author: Saito, Akihiko ; Kobayashi, Ryota ; Yamamoto, Suguru ; Kaseda, Ryohei ; Komochi, Koichi ; Nagatoishi, Satoru ; Tanaka, Takahiro ; Takemoto, Kazuya ; Sugita, Nanako ; Tsumoto, Kouhei ; Hirayama, Yoshiaki ; Aoki, Hiroyuki ; Narita, Ichiei ; Kuwahara, Shoji ; Kabasawa, Hideyuki ; Goto, Sawako ; Yoshida, Yutaka ; Endo, Taeko ; Hosojima, Michihiro

ABSTRACT:

Megalin is a multiligand endocytic receptor in proximal tubule epithelial cells (PTECs) that facilitates the reabsorption of certain nephrotoxic drugs. Notably, cilastatin competes with these drugs for binding to megalin. Patients with chronic kidney disease are at increased risk of contrast‐induced (CI) acute kidney injury, in which iodine‐mediated PTEC toxicity is a crucial pathogenic factor. This study investigated the interplay between megalin and CI‐PTEC injury, along with the protective effect of cilastatin, utilizing electron probe microanalysis, a mouse CI‐PTEC injury model, quartz crystal microbalance analysis, and binding assays with magnetic beads immobilized with iomeprol, a water‐soluble nonionic contrast medium (CM). Electron probe microanalysis revealed the reduced renal uptake of CMs in the kidney cortex of kidney‐specific conditional megalin‐knockout mice compared with controls. In the CI‐PTEC injury model using kidney‐specific conditional or mosaic megalin‐knockout mice, a significant reduction of vacuolization was observed in PTECs in the cortex compared with controls in the former, while co‐expression of megalin and kidney injury molecule‐1 was observed in the latter. These findings indicate that megalin is involved in the development of CI‐PTEC injury. Cilastatin inhibited the renal uptake of CMs and ameliorated CI‐PTEC injury in wild‐type mice. Of note, two distinct pathways of renal CM uptake were delineated, both of which cilastatin inhibited: the direct binding of CMs to megalin and an indirect route involving transcobalamin‐2, an endocytic megalin ligand, functioning as a CM carrier. Collectively, megalin governs the direct and indirect pathways in the development of CI‐PTEC injury, and cilastatin effectively impedes both.

01 Aug 2025·BMJ Case Reports

Iomeprol-induced acute generalised exanthematous pustulosis (AGEP)

Article

Author: Ojha, Sahana ; Dhamale, Suyog ; Singh, Gautam Kumar ; Randive, Prerana S.

Acute generalised exanthematous pustulosis (AGEP) is an uncommon but severe cutaneous adverse drug reaction characterised by the abrupt onset of numerous sterile, non-follicular pustules on erythematous and oedematous skin, often accompanied by fever and leucocytosis. Although medications are the primary aetiological factor, AGEP may also be precipitated by exposure to certain chemicals, dyes or infectious agents. Despite its low incidence, estimated at 1–5 cases per million each year, AGEP remains a clinically significant condition with potential for severe morbidity and, in rare cases, fatality.We report a case of AGEP in a woman in her 30s, triggered by exposure to the iodinated radiocontrast agent iomeprol. While AGEP induced by iodinated contrast media is rare, it represents an important diagnostic consideration, particularly in patients undergoing imaging studies. Early recognition, along with appropriate diagnostic strategies such as patch testing, is crucial for effective management and prevention of recurrence.

News (Medical) associated with Iomeprol

27 Jul 2022

·www.prnewswire.com

FDA Grants Import Discretion of Bracco's Iodinated Contrast Medium Iomeron® (iomeprol injection) to Address Supply Shortages

MILAN, July 27, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron® (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage. Iomeron® (iomeprol injection) is a nonionic iodinated contrast medium for intravascular use in adults in various imaging procedures. Currently registered in over 50 countries in Europe and Asia, it is not approved for use in the United States. The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August 2022. It is manufactured at two Bracco locations: BIPSO GmbH, Singen (Germany), and Patheon Italia S.p.A., Ferentino (Italy). Jeff Fleming, Chief Executive Officer, Bracco Diagnostics Inc., said, "Throughout its 95-year history, Bracco has always put people and innovation at the core of its business, and focused ongoing attention on patient health, safety, and quality of care. We are proud that the company has worked proactively with the FDA to address the shortage of iodinated contrast agents in the U.S. market." For more information on the temporary importation of Iomeron®, click here. About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer . Visit: . Bracco Imaging Press Office Duccio Manetti Global Communications Director +39 340 9016191 [email protected] Micaela Colamasi Senior PR Communication Manager +39 340 9775099 [email protected] Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Manager, Marketing Communications [email protected] D: +1 609-524-2777 SOURCE Bracco Diagnostics Inc.

100 Deals associated with Iomeprol

External Link

KEGG	Wiki	ATC	Drug Bank
D01719	Iomeprol	V08AB10	DB11705

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Contrast agents	China	Spin SpA	19 Jul 2005
Urethral Diseases	Japan	Bracco Japan Co., Ltd.	01 Apr 1994
Vascular Diseases	Japan	Bracco Japan Co., Ltd.	01 Apr 1994

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