E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients complying with tumours and undergoing radio- and/or chemotherapy for whom is mandatory to know the hypoxia component |
Pazienti con neoplasie da sottoporre a chemio- e/o radioterapia in cui sia cruciale valutare il grado di ipossia come fattore dirimente per la risposta al trattamento |
|
E.1.1.1 | Medical condition in easily understood language |
Patients complying with tumours and undergoing radio- and/or chemotherapy for whom is mandatory to know the hypoxia component |
Pazienti con neoplasie da sottoporre a chemio- e/o radioterapia in cui sia cruciale valutare il grado di ipossia come fattore dirimente per la risposta al trattamento |
|
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.1.2 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) |
|
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 PET/CT F18 FMISO in predicting relapse and in identifying patients who may take advantage from intensive care |
impatto della PET/CT con FMISO nel predire una recidiva ed identificare quali pazienti devono essere sottoposti ad un regime radio-/chemio-terapico più intenso |
|
E.2.2 | Secondary objectives of the trial |
analysis of HEAT-SHOCK protein TRAP1 expression involved in tumour cells protection |
analisi dei livelli di espressione della HEAT-SHOCK protein TRAP1 coinvolta nell’adattamento e nella protezione delle cellule tumorali allo stress ossidativo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients for whom is mandatory to assess the hypoxia and to monitor therapy efficay early |
Pazienti con neoplasie in cui sia cruciale valutare il grado di ipossia come fattore di risposta ai trattamenti |
|
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 FMISO PET/CT |
Accuratezza diagnostica dell'F18 FMISO PET/CT |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
metastatic assessment and correlation to neoplastic markers |
valutazione dell'estensione di malattia ; correlazione con markers tumorali |
|
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 | 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
| 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
|
study end with suitable number of patients according to statistical significancy |
completamento dello studio dopo 48 mesi ed escuzione dell'esame nel campione significativo |
|
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 |