E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastroenteropancreatic neuroendocrine tumor disease |
Tumores neuroendocrinos gastroenteropancreáticos |
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E.1.1.1 | Medical condition in easily understood language |
Gastroenteropancreatic neuroendocrine tumor disease |
Tumores neuroendocrinos gastroenteropancreáticos |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077560 |
E.1.2 | Term | Gastroenteropancreatic neuroendocrine tumor disease |
E.1.2 | System Organ Class | 100000004864 |
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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 |
1-To determine the sensitivity of 68Ga-DOTA PET-CT to detect tumors with high expression of RSST as compared to that of standard of care with octreotide labeled with gamma-emitting radionuclides
2- To identify the uptake patterns of 18F-FDG and 68Ga-DOTA PET-CT within subjects with well or moderately differentiated metastatic GEP-NET (ENETS grades 1 and 2).
3-To establish the correlation between the functional characteristics of hepatic lesions and the level of uptake of 18F-FDG and 68Ga.
4-To explore the impact of this combined imaging test on therapeutics.
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1-Analizar el incremento de eficacia diagnóstica de la PET-TC con 68Ga-DOTA en la identificación de lesiones que expresan RSST respecto al “standart of care” que se realiza mediante estudios con octreótido marcado con emisores gamma.
2-Determinar los diferentes patrones de fijación de 18F-FDG y de péptidos 68Ga-DOTA mediante PET-TC en un mismo individuo con metástasis de GEPNET bien y moderadamente diferenciados (grados 1 y 2 de la clasificación de la ENETS).
3-Correlacionar las características de imagen funcional de las lesiones hepáticas entre el nivel de fijación de 18F-FDG y péptidos 68Ga.
4-Valorar el impacto terapéutico que en el futuro podría desprenderse de la incorporación de esta metodología combinada. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
No aplicable |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study population will be composed of 30 patients with metastatic NET. A total of 15 patients with primary pancreatic tumor and 15 with primary extra-pancreatic tumor will be included.
Inclusion criteria:
1. Age > 18 years.
2. Signed informed consent form.
3. Grade 1 and 2 NETs according to WHO and ENETS classification.
4. Metastatic NETs.
5. Life expectancy > 12 months.
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La población del estudio la compondrán 30 pacientes con NET metastáticos. Se incluiran 15 pacientes con primario de origen pancreático y 15 pacientes con primario de origen extra-pancreático.
Los criterios de inclusión serán:
1. Pacientes > 18 años.
2. Pacientes que hayan firmado el consentimiento informado.
3. NETs de Grados 1 y 2 según las clasificaciones de la WHO y ENETS.
4. NETs con metástasis.
5. Esperanza de vida > 12 meses. |
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E.4 | Principal exclusion criteria |
1. Grade 3 NET according to WHO and ENETS classification.
2. Previous systemic radiopharmaceutical therapy.
4. Pregnancy
5. High-risk disease (cardiovascular, pulmonary...)
6. Chronic liver disease
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1. NETs de Grado 3 según las clasificaciones de la WHO y ENETS.
2. Pacientes que ya hayan recibido un tratamiento sistémico con radiofármacos.
4. Embarazo
5. Enfermedad de alto riesgo (cardiovascular, pulmonar...)
6. Hepatopatía crónica |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of new lesions detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG.
2. Number of affected organs detected with PET-CT with 68Ga-DOTA compared to PET-CT with 18F-FDG |
1. Número de nuevas lesiones detectadas con la PET-TC con 68Ga-DOTA respecto a la PET-TC con 18F-FDG.
2. Número de órganos afectados detectados con la PET-TC con 68Ga-DOTA respecto a la PET-TC con 18F-FDG.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Both comparative imaging studies will be performed after having performed both tests in each of the patients included in the trial. |
Ambos estudios comparativos de imagen se realizarán tras haber realizado ambas pruebas en cada uno de los pacientes incluidos en el ensayo. |
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E.5.2 | Secondary end point(s) |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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
|
2 days after the patient has undergone PET-CT PET-CT with 68Ga-DOTA-peptides |
2 días después de que el paciente se haya sometido al PET-TC PET-TC con 68Ga-DOTA-péptidos |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 3 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 3 |