Indication for POSITRON EMISSION TOMOGRAPHY (PET MeDRA 9.0 LLT 10036223) and Computed tomography (Computerized tomography (CT MeDRA 9.0 LLT 10062404) in patients with highly suspected or proved malignant liver lesions MedDRA version: 8.1 Level: LLT Classification code 10025623 Term: Malignant liver tumor
Conditions
Interventions
Trade Name: Imeron 400 MCT
Product Name: Imeron 400 MCT
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOMEPROL
CAS Number: 78649-41-9
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Bracco ALTANA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with highly suspected or proved malignant liver lesions - Patient with given indication for PET and CT - Patient is adult (age >or =18 years), conscious and co-operative - 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: - Intra-vascular CT contrast agent procedure within 48 hrs preceding the PET/CT examination - Hyperthyroidism (TSH below 0.3 mU/L) - Renal insufficiency (serum creatinine > 1.5 mg/dL) - Hypersensitivity to iodinated contrast media or significant allergic disposition - Participation in a clinical trial within the past 30 days - Previous participation in this clinical trial - Patient is female and pregnant or nursing - Patient is female and the possibility of pregnancy cannot be excluded from one of the following points: *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) - Patient is institutionalized by law - Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): This is an exploratory feasibility study. Primary endpoints/variables are not defined.;Main Objective: To explore the influence of Iomeprol 400 on PET of the liver by: - Comparing Standard Uptake Values (SUV) of liver lesions and normal liver tissue between precontrast-CT corrected, arterial-phase-CT corrected, portal-venous-phase-CT corrected, and late-phase CT corrected PET maps - Comparing qualitative assessments obtained on the basis of PET maps which were corrected with precontrast CT, arterial-phase CT, portal-venous-phase CT, and late-phase CT; and To show the usefulness of Iomeprol 400 in multidetector CT of the liver by: - Comparing contrast density measurements (HU) of liver lesions and normal liver tissue between precontrast CT, arterial-phase CT, portal-venous-phase CT and late phase CT - Comparing qualitative assessments between images of precontrast CT, arterial-phase CT, portal-venous-phase CT and late phase CT. | — |
Countries
Germany
Outcome results
None listed