E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025623 |
E.1.2 | Term | Malignant liver tumor |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
This is an exploratory feasibility study. Primary endpoints/variables are not defined. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |