E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients complying with cancer for whom is mandatory to know the replicative cellular activty |
Pazienti con neoplasie in cui sia cruciale valutare l’attivita' proliferativa cellulare prima durante e dopo interventi terapici |
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E.1.1.1 | Medical condition in easily understood language |
patients complying with cancer for whom is mandatory to know the replicative cellular activty rather than energetic metabolism |
Pazienti con neoplasie in cui sia cruciale valutare l’attivita' proliferativa cellulare prima durante e dopo interventi terapici piuttosto che il metabolismo energetico |
|
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 |
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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 | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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 |
Impact of F18 FLT PET/CT for replicative evaluation in staging, restaging and therapy assessment of tumours rather than energetic metabolism |
Impatto della F18 FLT PET/CT come marcatore della replicazione cellulare nello staging, restaging e valutazione della terapia delle neoplasie indipendentemente dal metabolismo energetico |
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E.2.2 | Secondary objectives of the trial |
correlation to angiogenetic markers and EGFR mutations |
L’uptake potrebbe essere correlato a markers dell’angiogenesi (VEGF) o replicativi (Ki-67 and Glut-1) e a mutazioni che conducono all’ overespressione dell’EGFR. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients for whom is mandatory to know cellular replication and to monitor therpy efficacy early |
• Pazienti con neoplasie in cui sia cruciale valutare l’attività proliferativa cellulare prima durante e dopo interventi terapici, in particolare i su esposti tipi di neoplasia
• Pazienti maschi e femmine con malattia accertata con o senza cito- istologia in cui sia necessaria una stadiazione, una ristadiazione od un monitoraggio post-terapico |
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E.4 | Principal exclusion criteria |
• Age <18 yrs o >90 yrs |
• Età <18 anni. o >90 anni. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Diagnostic accuracy of F18 FLT PET/CT |
Accuratezza diagnostica della F18 FLT PET/CT |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
metastatic assessment and correlation to neoplastic markers |
valutazione della estensione di malattia; correlazione con markers tumorali |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
study end with suitable number of patientsaccording to statistical significancy |
completamento dello studio dopo 48 mesi ed esecuzione dell'esame nel campione significativo |
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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 | 48 |
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 | 48 |
E.8.9.2 | In all countries concerned by the trial days | 0 |