E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastro-entero-pancreatic neuroendocrine tumors |
Tumori neuroendocrini del tratto gastro-entero-pancreatico
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E.1.1.1 | Medical condition in easily understood language |
Neuroendocrine neoplasms of the digestive tract |
Neoplasie neuroendocrine del tratto digestivo
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057270 |
E.1.2 | Term | Neuroendocrine carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057270 |
E.1.2 | Term | Neuroendocrine carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 assess the sensitivity and specificity of the probe to detect tumor areas that can picked up by the radiotracer, with the purpose to obtain information about the capability of the probe to detect tumor margins and lymph nodes potentially pathological. |
Valutare la sensibilit¿ e la specificit¿ della sonda nel rilevare le aree tumorali captanti il radiotracciante e poter quindi ottenere indicazioni sulle sue capacit¿ di visualizzazione anche dei margini tumorali e dei linfonodi potenzialmente patologici. |
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E.2.2 | Secondary objectives of the trial |
¿ Evaluation of minimal activity that should be given to the patient and establishment the procedure ¿ Rating of irradiation staff ¿ Optimization of the probe ¿ Clinical-laboratory evaluation (patient safety) ¿ Toxicity
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¿ Valutazione della attivit¿ minima che occorre somministrare al paziente e definizione della procedura per stabilirla paziente per paziente ¿ Valutazione dell¿irraggiamento del personale ¿ Ottimizzazione della sonda ¿ Valutazione clinico-laboratoristica (sicurezza paziente) ¿ Tossicit¿
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Patients of both sexes aged over 18 years b) Patients with histologically documented diagnosis of GEP-NET candidates for surgery R0 or R2. c) Presence of a PET / CT with 68Ga-DOTATOC showing a significant uptake (> than the liver) of the tracer at the tumor (SSR-positive) d) Functionality marrow, liver, kidney and heart check with instrumental tests (ECG) and laboratory (blood count, creatinine, transaminases, gamma-GT, alkaline phosphatase, sodium and potassium) e) Signed informed consent f) a negative pregnancy test (blood dosage of beta HCG) not older than 7 days is required in women in premenopausal status
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a) Pazienti di entrambi i sessi di età superiore ai 18 anni b) Pazienti con diagnosi istologicamente documentata di GEP-NET candidati a chirurgia R0 o R2. c) Presenza di un esame PET/TC con 68Ga-DOTATOC che mostri un significativa captazione (>rispetto al fegato) del tracciante a livello del tumore (SSR-positivo) d) Funzionalità midollare, epatica, renale e cardiaca verificate con esami strumentali (ECG) e di laboratorio (emocromo, dosaggi ematici creatinina, transaminasi, gamma-GT, fosfatasi alcalina, sodio e potassio) e) Sottoscrizione consenso informato f) Nelle donne in età riproduttiva è necessario un test di gravidanza negativo (dosaggio ematico della beta HCG) non più vecchio di 7 giorni |
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E.4 | Principal exclusion criteria |
a) Patient history of malignant tumors with treatment ongoing except for basal cell carcinoma in situ and cervical cancer radically removed b) Known intolerance to medical contrast medium and / or previous anaphylactic shock c) Women who are pregnant or nursing, GEP-NET recurrence and considered inoperable
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a) Pregressi tumori maligni in altre localizzazioni in corso di terapia o comunque non considerati guariti ad eccezione basaliomi in situ e tumori cervicali radicalmente asportati b) Allergia nota a mezzi di contrasto e/o pregressi shock anafilattici c) Donne in stato di gravidanza o allattamento GEP-NET recidivi e considerati non operabili
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E.5 End points |
E.5.1 | Primary end point(s) |
To develop a method that allows the complete resection not only for GEP-NETs but also of other isotypes tumor that express the somatostatin receptors. |
Sviluppare una metodica che permetta il raggiungimento di una resezione completa non solo nella chirurgia dei GEP-NET ma anche di altri isotipi tumorali che esprimano i recettori per la somatostatina. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Just after surgery we expect to obtain information regarding radioactivity emitted by the tumor revealed by a probe |
subito dopo la chirurgia attraverso una valutazione della radioattività emessa dal tumore rivelata da una sonda |
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E.5.2 | Secondary end point(s) |
¿ Evaluation of minimal activity that should be given to the patient and establishment the procedure ; ¿ Rating of irradiation staff; ¿ Optimization of the probe; ¿ Toxicity |
¿ Valutazione della attivit¿ minima che occorre somministrare al paziente e definizione della procedura ; ¿ Valutazione dell¿irraggiamento del personale; ¿ Ottimizzazione della sonda; ¿ Tossicit¿ |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 month after treatment; 1 month after treatment; 3-6 mesi; 3- 6 mesi |
1 mese dopo il trattamento; 1 mese dopo il trattamento; 3-6 mesi; 3 - 6 mesi |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |