Comparison of Reduced versus Standard Dose Iomeprol in Spectral CT for the Monitoring of Thoracic Neoplasms: A Randomized, Crossover, Non-Inferiority Trial

The primary objective is to perform a qualitative and quantitative comparison of two iodinated contrast medium administration protocols in the oncologic staging of thoracic neoplasms using spectral CT. The study evaluates the non-inferiority of a reduced dose protocol, utilizing half the standard volume, against a standard dose protocol by analyzing vascular attenuation, signal-to-noise ratio in the pulmonary arteries and aorta, and hepatic attenuation. Additionally, the image quality and image noise are assessed to determine clinical diagnostic equivalence. The secondary objective includes the assessment of inter-reader agreement between two observers during the evaluation of the analyzed parameters. 1: Diagnosis.

The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients between the ages of 18 and 64 years. Participants are selected based on a referral for contrast-enhanced CT for the staging of a primary pulmonary malignancy or pleural malignancy, occurring either at the time of initial diagnosis or during disease follow-up. Eligible individuals are those diagnosed with a thoracic neoplasm.

This randomized, crossover, non-inferiority clinical trial evaluates two protocols for administering an iodinated contrast medium during spectral CT imaging for the monitoring of thoracic neoplasms. The research compares a protocol using half the standard dose of iomeprol against a protocol using the standard dose. The primary objectives involve the qualitative and quantitative analysis of vascular attenuation, signal-to-noise ratio in the pulmonary arteries and aorta, hepatic attenuation, and a subjective assessment of image quality and image noise. A secondary objective is to analyze the agreement between two readers regarding these parameters. The study includes patients older than 18 years undergoing contrast-enhanced thoracoabdominopelvic CT for the staging of primary pulmonary or pleural malignancy. The total duration of the trial is estimated to span from January 2026 to December 2026.

The experimental treatment consists of iomeprol, administered as Iomeron 400 mgI/ml solution for injection. The administration is performed via intravenous injection at a concentration of 100 g/l.

The non-experimental protocol involves the administration of a standard dose of iodinated contrast medium. This comparator is utilized to evaluate the non-inferiority of the reduced dose protocol in the oncologic staging of thoracic neoplasms using spectral CT.

Efficacy is assessed through a comparative analysis of two iodinated contrast administration protocols in the staging of thoracic neoplasms using spectral CT. The primary endpoints include the evaluation of vascular attenuation and the signal-to-noise ratio within the pulmonary arteries and the aorta, as well as hepatic attenuation and the corresponding signal-to-noise ratio. Additionally, a subjective assessment of overall image quality and image noise will be performed.

Secondary efficacy evaluation involves analyzing the agreement between two readers during the assessment of the specified parameters.