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This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.
Patient data will be collected from medical records after obtaining consent and retrospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutathera |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutetium [177Lu] oxodotreotide/dotatate | Drug | Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first. | Up to 12 months |
| Overall survival (OS) | Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause. | Up to 12 months |
| Overall response rate (ORR) | Is determined by imaging technique according to RECIST criteria v1.1 and is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1 | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of the population . | Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution. | Up to 12 months |
| Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mercedes Dr Mitjavila Casanovas, MD-PhD | Contact | 911916000 | 46261 | mercedes.mitjavila@salud.madrid.org |
| Paula Dr Jiménez Fonseca, MD-PhD | Contact | 985106121 | 36582 | palucaji@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mercedes Dr Mitjavila Casanovas, MD-PhD | Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Santiago | Recruiting | Santiago de Compostela | A Coruña | 15706 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36877234 | Derived | Mitjavila M, Jimenez-Fonseca P, Bello P, Pubul V, Percovich JC, Garcia-Burillo A, Hernando J, Arbizu J, Rodeno E, Estorch M, Llana B, Castellon M, Garcia-Canamaque L, Gajate P, Riesco MC, Miguel MB, Balaguer-Munoz D, Custodio A, Cano JM, Repetto A, Garcia-Alonso P, Muros MA, Vercher-Conejero JL, Carmona-Bayonas A. Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study. Eur J Nucl Med Mol Imaging. 2023 Jul;50(8):2486-2500. doi: 10.1007/s00259-023-06166-8. Epub 2023 Mar 6. |
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| Lutetium [177Lu] oxodotreotide/dotatate | Device | Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial) |
|
|
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
| Up to 12 months |
| Prognostic factors | Correlation of possible prognostic factors with clinical effectiveness outcomes. | Up to 12 months |
| Areas for improvement care | Identification of areas for improvement in the management and selection of patients for treatment with lutathera | Up to 12 months |
| Health-related Quality of Life (HRQoL) | Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire.The minimum value ( 1%) and the maximum value (100%), and higher scores mean a better outcome. | Up to 12 months |
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Andalusia | 18014 | Spain |
|
| Hospital Unviersitari Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 07120 | Spain |
|
| Hospital Universitari de Bellvitge | Not yet recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
|
| Hospital Universitario de Getafe | Not yet recruiting | Getafe | Madrid | 28905 | Spain |
|
| Hospital Univeritario Puerta de Hierro | Not yet recruiting | Majadahonda | Madrid | 28222 | Spain |
|
| Hospital ClÃnico Universitario Virgen de la Arrixaca | Recruiting | El Palmar | Murcia | 30120 | Spain |
|
| ClÃnica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | 08041 | Spain |
|
| Hospital Universitario de Burgos | Recruiting | Burgos | 09006 | Spain |
|
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
|
| Hospital General Universitario Gregorio Marañón | Not yet recruiting | Madrid | 28007 | Spain |
|
| Hospital Universitario Ramon y Cajal | Not yet recruiting | Madrid | 28034 | Spain |
|
| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | 28041 | Spain |
|
| Hospital Universitario La Paz | Not yet recruiting | Madrid | 28046 | Spain |
|
| Hospital Universitario HM Sanchinarro | Not yet recruiting | Madrid | 28050 | Spain |
|
| Hospital Universitario de Navarra | Recruiting | Pamplona | 31008 | Spain |
|
| Hospital Universitario Doctor Peset | Recruiting | Valencia | 46017 | Spain |
|
| Hospital Universitario La Fe | Recruiting | Valencia | 46026 | Spain |
|
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D007414 | Intestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D008187 | Lutetium |
| C000615061 | Lutetium-177 |
| C000718307 | copper dotatate CU-64 |
| C447941 | lutetium Lu 177 dotatate |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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