E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Etude phase III, descriprtive et prospective, destinée au diagnostic des lésions solides du pancréas |
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MedDRA Classification |
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 |
Evaluer la sensibilité et la spécificité de l'échoendoscopie de contraste (EEC) pour le diagnostic des lésions solides du pancréas
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E.2.2 | Secondary objectives of the trial |
Décrire et évaluer le type de vascularisation des lésions solides du pancréas en fonction de l'histologie finale. Evaluer la vascularisation spécifique des tumeurs endocrines en fonction de leur différenciation histologique. Evaluer l'intérêt de l'EEC pour cibler la zone préférentielle de ponction. Evaluer en intra et inter-observateur l'interprétation du rehaussement avec Sonovue. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patient âgé de plus de 18 ans -Patient présentant une lésion solide du pancréas -Patient présentant une lésion mixte du pancréas dont la composante kystique est inférieure à 25% du volume tumoral -Absence de participation à une autre étude clinique -Consentement éclairé signé |
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E.4 | Principal exclusion criteria |
-Patient âgé de moins de 18 ans -Grossesse ou allaitement en cours, absence de contraception efficace -Patient ASA 4, ASA 5 -Insuffisance cardiaque grade III, IV -Syndrôme coronarien inférieur à 6 mois ou cardiopathie ischémique instable -Troubles sévères du rythme cardiaque -Hypertension artérielle non contrôlée -Hpertension artérielle pulmonaire sévère -Syndrôme de détresse respiratoire -Hypersensibilité aux hexafluorures de souffre -Personne incapable de donner personnellement son consentement, dont majeur sous tutelle et personne en situation d'urgence -Absence de consentement éclairé signé
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E.5 End points |
E.5.1 | Primary end point(s) |
La sensibilité et la spécificité de l'Echoendoscopie de contraste pour le diagnostic des lésions solides du pancréas |
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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 | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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
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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 | 18 |
E.8.9.1 | In the Member State concerned days | |