SUSPECTED PULMONARY EMBOLI AND/OR DEEP VENOUS THROMBOSIS MedDRA code for deep venous thrombosis: version 7 LLT 0.913
Conditions
Interventions
Trade Name: IOMERON-300
IOMERON-400
Product Name: IOMERON
Product Code: N/A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOMEPROL
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Bracco Imaging S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are at least 40 years of age 2. With suspected pulmonary embolism, 3. Referred for a MS-CTA examination of the pulmonary arteries, 4. Provide written Informed Consent and are willing to comply with protocol requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. patients with a history of hypersensitivity to iodine-containing compounds, 2. patients with severe congestive heart failure (class III and IV according to NYHA classification), 3. patients with a severe renal failure (serum creatinine > 2.5 mg/mL), 4. patients having undergone any other radiological procedure utilising x-ray contrast media during the 24 hour period preceding multislice, spiral, computed tomography, 5. Is a pregnant or lactating female. Exclude the possibility of pregnancy: - by testing on site at the institution (serum or urine ßHCG) within 1 hour prior to the start of study agent administration - by questioning the patient - by history (e.g., tubal ligation or hysterectomy) - post-menopausal with a minimum 1 year without menses. 6. Has received an investigational compound within 30 days before admission into this study, 7. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations, 8. Is determined by clinical physician and/or the Investigator that the subject is clinically unsuitable for the study,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two concentrations of Iomeron (300 mgI/mL and 400 mgI/mL) in multislice CT angiography (MS-CTA) of the pulmonary arteries in terms of attenuation values (HU), measured at different levels of the pulmonary arteries (main pulmonary artery, right and left pulmonary arteries, lobar arteries, and selected segmental arteries).;Secondary Objective: Quantitative Comparison of the two study groups for: 1. lesion contrast for pulmonary emboli (if applicable) 2. attenuation values (HU) in MS-CT-phlebography (MS-CTP) of the major deep venous system of the lower extremities (from the popliteal veins to the infrarenal portion of the inferior vena cava) 3. lesion contrast for deep venous thrombi (if applicable) Qualitative Comparison of the two study groups for: 1. the presence of artefacts due to the contrast agent 2. the quality of enhancement and visualization of the pulmonary arteries in MS-CTA 3. the quality of enhancement and visualization of the lower extremity veins in MS-CTP 1. the safety of the two Iomeron? concentrations ;Primary end point(s): | — |
Countries
Austria
Outcome results
None listed