Indication for Computed tomography (Computerized tomography (CT MeDRA 9.0 LLT 10062404)) and Metastatic renal carcinoma (MeDRA 9.0 LLT 10050076) MedDRA version: 8.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma
Conditions
Interventions
Trade Name: Imeron 300
Product Name: Imeron 300
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOMEPROL
CAS Number: 78649-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
Bracco Imaging Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Renal carcinoma with at least one abdominal mass (if possible at the kidney level) larger than 2 cm (largest axial diameter); 2. Indication for Computed Tomography due to re-staging before the start of a new antiangiogenic treatment; 3. Patient is >= 35 years old, conscious and co-operative; 4. Written Informed Consent to participate in the study. 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. Hyperthyroidism (TSH below 0.3 mU/L); 2. Renal insufficiency (serum creatinine > 1.5 mg/dL); 3. Hypersensitivity to iodinated contrast media or significant allergic disposition; 4. Insulin-dependent diabetes mellitus or metformin medication (discontinuation for 48 h enables CT examination of patients with normal renal function); 5. Acute stroke; 6. Known epilepsy that is currently active; 7. Planned radioactive iodine therapy; 8. Participation in a clinical trial within the past 30 days; 9. Previous participation in this clinical trial; 10. Alcohol or drug abuse; 11. Patient is female and pregnant or nursing; 12. Patient is female and the possibility of pregnancy cannot be excluded by one of the following methods: - surgical sterilization (method has to be recorded on medical history form), - confirmed post-menopausal (with minimum 1-year history without menstruation), - negative pregnancy test (confirmed via ß-HCG measurement); 13. Patient is institutionalized by law; 14. Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion 15. Inadequate peripheral veins, which would not allow for the required fast administration of contrast agent (via 18 gauge needle).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantitatively compare the enhancement properties in perfusion CT between injection protocols using a high iodine flux [gI/s] with Iomeprol 400 and a lower iodine flux with Iomeprol 300, at equal injection rates [mL/s].;Primary end point(s): The primary efficacy variable is the maximum contrast enhancement (increase of contrast density [Hounsfield units, HU]) in the abdominal aorta (arterial input function).;Secondary Objective: To compare between the Iomeprol 300 and Iomeprol 400 injection protocols: - Contrast enhancement (Hounsfield units (HU)) and signal-to-noise indices, in normal organ and tumor tissues, in CT perfusion images and in venous phase CT images; - Contrast dynamics in terms of slope [HU/s], slope to maximum enhancement, maximum initial slope [HU/s], the time after start of contrast injection to maximum enhancement [s], the rise time to maximum [s], as well as the integral of enhancement over time [HUs] of enhancement time curves obtained separately for all regions of interest (ROIs);- Calculated perfusion parameters (absolute values and standard deviation (SD)), and signal-to-noise indices (value/SD); - Qualitative evaluations of tumor opacification and diagnostic adequacy of parameter maps. To correlate the calculated perfusion parameters with the subsequent change of tumor size (treatment effect) in follow-up examinations | — |
Countries
Germany
Outcome results
None listed