E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tumors od neuroendrocrine origin |
Neoplasie umane di derivazione neuroendocrina |
|
E.1.1.1 | Medical condition in easily understood language |
Neruoendocrine tumor |
Tumori neuroendrocrini |
|
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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
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 |
Diagnosys - Diagnosys of neuroendocrine tumors by PET with 68Ga-DOTANOC |
Diagnosi - Valutare il ruolo della PET con 68Ga-DOTANOC nella diagnostica per immagini di neoplasie di derivazione neuroendocrina |
|
E.2.2 | Secondary objectives of the trial |
Impact of the method in the definition of plain of treatment (hormone therapy vs chemiotherapy). |
Impatto della metodica nella definizione del piano di trattamento (terapia ormonale vs chemioterapia) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 years; male or female; tumor of neuroendocrine origine |
Età > 18 anni; entrambi i sessi; portatori di neoplasie di derivazione neuroendocrina |
|
E.4 | Principal exclusion criteria |
< 18 years; pregnancy; breast-feed; incapable to intend |
< 18 anni; gravidanza; allattamento; incapacità di intendere e volere |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of lesions identified on CT vs number of lesions identified by PET with 68Ga-DOTANOC |
Evidenziare il numero di lesioni riconoscibili alla TC rispetto al numero di lesioni positive alla PET con 68Ga-DOTANOC e pertanto esprimenti somatostatina. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Impact of the method in the definition of plain of treatment (hormone therapy vs chemiotherapy). |
Impatto della metodica nella definizione del piano di trattamento (terapia ormonale vs chemioterapia) valutando i dati dei pazienti che potranno avvantaggiare della terapia recettoriale, nei confronti dei dati disponibili in letteratura. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
vs TC convenzionale |
vs conventionale TC |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
vs TC convenzionale |
vs conventional TC |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.6 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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |