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Spanish Series of Patients Treated With the Radionuclide Lutetium177

NCT ID: NCT04949282

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Patient data will be collected from medical records after obtaining consent and retrospectively.

Conditions

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Neuroendocrine Tumors Intestinal Neoplasms Pancreatic Neoplasms Stomach Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Gastrointestinal Disease Intestinal Diseases Pancreatic Disease Endocrine System Diseases

Keywords

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GEP-NET Gastro-Entero-Pancreatic Neuroendocrine Tumour Luthatera Somatostatin receptor positive tumour

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lutathera

Lutetium [177Lu] oxodotreotide/dotatate

Intervention Type DRUG

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Lutetium [177Lu] oxodotreotide/dotatate

Intervention Type DEVICE

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Interventions

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Lutetium [177Lu] oxodotreotide/dotatate

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Intervention Type DRUG

Lutetium [177Lu] oxodotreotide/dotatate

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)

Intervention Type DEVICE

Other Intervention Names

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Lutathera Lutathera

Eligibility Criteria

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Inclusion Criteria

* Written informed consent must be obtained prior to any data collection.
* Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour
* Aged ≥18 years.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Medicina Nuclear e Imagen Molecular

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)

Locations

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Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Site Status RECRUITING

Hospital Unviersitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Univeritario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Burgos

Burgos, , Spain

Site Status RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: CONTACT

Phone: 911916000

Email: [email protected]

Paula Dr Jiménez Fonseca, MD-PhD

Role: CONTACT

Phone: 985106121

Email: [email protected]

Facility Contacts

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Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

Mercedes Dr Mitjavila Casanovas, MD-PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36877234 (View on PubMed)

Other Identifiers

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SEM-LUT-2020-01

Identifier Type: -

Identifier Source: org_study_id