E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
thyroid carcinoma |
• CARCINOMA DELLA TIROIDE |
|
E.1.1.1 | Medical condition in easily understood language |
thyroid carcinoma |
CARCINOMA DELLA TIROIDE |
|
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 | LLT |
E.1.2 | Classification code | 10043655 |
E.1.2 | Term | Thryoid neoplasia |
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 |
Main objective of the study is to evaluate the role of PET/CT with 124I for calculating an individual dose before treatment in patients affected by thyroid carcinoma; all cases are scheduled for radiomethabolic treatment with 131I as standard of care |
Il principale obiettivo di questo studio è quello di valutare il ruolo della PET/TC con 124I nell’ effettuare una stima dosimetrica pre-trattamento individualizzata in pazienti affetti da carcinoma della tiroide, che dovranno essere sottoposti nell’ambito del consolidato percorso assistenziale, a terapia radiometabolica con 131I. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective is to evaluate the difference between dose calculated using kinetic curves of 124I as compared to doses estimated with ICRP tables |
Un secondo obiettivo consiste nel valutare se la dose calcolata mediante analisi delle curve di cinetica del radiofarmaco 124I differisce significativamente dalla dose calcolata mediante tabelle dosimetriche ICRP. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with diagnosis of thyroid carcinoma, already operated by radical tyroidectomy, with lung or bone metastases showing radioiodine uptake; those patients are treated with radiomethabolic therapy using 131I
age superior or egual to 18years
male and female
signed informed consent |
• pazienti con diagnosi di carcinoma della tiroide, già sottoposti a tiroidectomia radicale, con metastasi polmonari o ossee iodiocaptanti, il cui trattamento di elezione è la terapia radiometabolica con 131I.
• età maggiore o uguale 18 anni
• entrambi i sessi
• firma del consenso informato |
|
E.4 | Principal exclusion criteria |
pregnancy
breastfeeding
patients in emergency situations
patients of unsound mind |
• donne in stato di gravidanza
• donne durante l’allattamento
• soggetti in situazioni di emergenza
• soggetti non in grado di intendere e di volere |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference between clinical outcomes (response to treatment and disease free survival) in the experimental group (patients treated with dose individually calculated using 124I) as compared to the control group (retrospective: data obtained from files of patients treated with estimated dose using ICRP tables) |
Differenza tra outcomes clinici (risposta al trattamento e periodo libero da malattia) del gruppo sperimentale (pazienti trattati con dosimetria individualizzata) rispetto al gruppo di controllo (di natura retrospettiva: dati ricavati da cartelle cliniche di pazienti trattati con dosi calcolate mediante tabelle dosimetriche ICRP) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after the single dose of Na 124-I. |
6 mesi dopo la somministrazione singola del Na 124-I |
|
E.5.2 | Secondary end point(s) |
Difference between individual dose as calculated with kinetic curves of 124I and dose as estimated with ICRP tables |
Differenza tra dose calcolata mediante curve di cinetica del radiofarmaco 124I e dose calcolata mediante tabelle ICRP |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time between Na 124-I somministration and start of treatment with 131-I. |
Tempo fra dose singola del Na 124-I e inizio terapia con 131-I. |
|
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 | 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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 |
gruppo di controllo retrospettivo |
retrospective controll group |
|
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 |
gruppo di controllo retrospettivo |
retrospective controll group |
|
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
|
Immediately after the end of radiotherapy. |
Immediatamente dopo la fine del trattamento radioterapico. |
|
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 | 44 |
E.8.9.1 | In the Member State concerned days | 0 |