E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
En pacientes con neoplasia diferenciada de tiroides, y con sospecha de recidiva, con valores de TG elevados y rastreo con radioyodo negativos, se estudiará la expresión de los receptores para la somatostatina, para poder diagnosticar mejor posibles recidivas locorregionales o a distáncia. |
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MedDRA Classification |
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 |
Establecer una nueva técnica diagnóstica que permita detectar recurrencias locales o a distancia de una neoplasia diferenciada de tiroides, e identificar qué pacientes pueden ser tratados con análogos de la somatostatina. |
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E.2.2 | Secondary objectives of the trial |
- Implementar la metodología de la gammagrafía/SPECT con 99mTc-Depreotide en pacientes con CDT. - Evaluar la utilidad de la gammagrafía con 99mTc-Depreotide en la detección de recidivas en pacientes con CDT ya tratado. - Comparar el rendimiento de la gammagrafía/SPECT con 99mTc-Depreotide en la detección de recidivas de CDT con el de las otras técnicas de diagnóstico convencional por imagen (ecografía cervical, TAC, PET con FDG). - Evaluar la capacidad de la gammagrafía/SPECT con 99mTc-Depreotide en el análisis de la distribución y concentración de los receptores para somatostatina en las recidivas de CDT. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pacientes con carcinoma diferenciado de tiroides (papilar o folicular) ya tratado con cirugía y radioyodo, que presentan rastreo corporal total con radioyodo a dosis terapéuticas negativo y valores de TG elevada (TG estimulada > 2 ng/ml y evidencia de recurrencia por otras técnicas de imagen convencional; TG estimulada > 10 ng/ml). |
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E.4 | Principal exclusion criteria |
- Edad inferior a 18 años. - Embarazo. - Lactancia materna. - Otra enfermedad neoplásica activa. - Coexistencia de otra enfermedad grave. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Detección de recurrencia locorregional o a distancia mediante la expresión de los receptores para la somatostatina, para poder plantearse opción terapéutica con análogos para la somatostatina. |
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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 | Yes |
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 | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.1.7.1 | Other trial design description |
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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 |
Otras técnicas de imagen convencional |
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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.8.5 | 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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |