IOMEPROL for Thoracic neoplasm|Primary pulmonary malignancy|Pleural malignancy

Inclusion criteria

• {"criterion_text":"- All consecutive patients older than 18 years referred to our department for contrast-enhanced thoracoabdominopelvic CT for staging of a primary pulmonary or pleural malignancy, either at initial diagnosis or during disease follow-up, will be included."}

Exclusion criteria

• {"criterion_text":"- Patients with known allergy or hypersensitivity to iodinated contrast media and/or any of its excipients."}
• {"criterion_text":"- Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min."}
• {"criterion_text":"- Patient refusal to participate in the study or inability to provide informed consent."}
• {"criterion_text":"- Incomplete administration of contrast medium according to the assigned protocol due to issues with venous access, injector malfunction, central venous access, or related technical problems."}
• {"criterion_text":"- Body weight <50 kg or >90 kg."}
• {"criterion_text":"- Inability to perform the examination on the spectral CT scanner due to equipment malfunction, unavailability, or related technical issues."}
• {"criterion_text":"- Pregnant women or women with a possibility of being pregnant."}

Primary endpoints

• {"endpoint_text":"- Vascular attenuation and signal-to-noise ratio.","definition_or_measurement_approach":"Quantitative measurement of vascular attenuation and signal-to-noise ratio in vascular structures (specifically pulmonary arteries and aorta) comparing half-dose vs standard-dose contrast protocols."}
• {"endpoint_text":"- Hepatic attenuation and signal-to-noise ratio.","definition_or_measurement_approach":"Quantitative measurement of hepatic attenuation and signal-to-noise ratio comparing the two contrast administration protocols."}
• {"endpoint_text":"- Subjective assessment of overall image quality and image noise.","definition_or_measurement_approach":"Subjective image quality and image noise assessed by readers (reader-based subjective assessment) comparing the two protocols."}

Secondary endpoints

• {"endpoint_text":"- To analyze the agreement between two readers in the assessment of the evaluated parameters.","definition_or_measurement_approach":"Assessment of inter-reader agreement between two readers in the evaluation of vascular/hepatic attenuation, signal-to-noise ratio, and subjective image quality/noise."}

Spain

Earliest CTIS Part Ii Submission Date

16-01-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

60

Number Of Sites

1

Number Of Participants

52

Primary sponsor

Full Name

Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain