Spanish Series of Patients Treated With the Radionuclide Lutetium177

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04949282
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sociedad Española de Medicina Nuclear e Imagen Molecular
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mercedes Dr Mitjavila Casanovas, MD-PhD
Principal Investigator Affiliation Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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

Arms & Interventions

Arms

: Lutathera

Interventions

Drug: - Lutetium [177Lu] oxodotreotide/dotatate

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

Device: - Lutetium [177Lu] oxodotreotide/dotatate

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Santiago De Compostela, A Coruña, Spain

Status

Recruiting

Address

Hospital Clínico Universitario de Santiago

Santiago De Compostela, A Coruña, 15706

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Granada, Andalucia, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de las Nieves

Granada, Andalucia, 18014

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Oviedo, Asturias, Spain

Status

Recruiting

Address

Hospital Universitario Central de Asturias

Oviedo, Asturias, 33011

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Universitari de Bellvitge

Hospitalet de Llobregat, Barcelona, 08907

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Unviersitari Son Espases, Palma De Mallorca, Islas Baleares, Spain

Status

Recruiting

Address

Hospital Unviersitari Son Espases

Palma De Mallorca, Islas Baleares, 07120

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario de Getafe, Getafe, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario de Getafe

Getafe, Madrid, 28905

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Univeritario Puerta de Hierro, Majadahonda, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Univeritario Puerta de Hierro

Majadahonda, Madrid, 28222

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

El Palmar, Murcia, Spain

Status

Recruiting

Address

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Clínica Universidad de Navarra, Pamplona, Navarra, Spain

Status

Recruiting

Address

Clínica Universidad de Navarra

Pamplona, Navarra, 31008

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital de la Santa Creu i Sant Pau

Barcelona, , 08041

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario de Burgos, Burgos, Spain

Status

Recruiting

Address

Hospital Universitario de Burgos

Burgos, , 09006

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Ciudad Real, Spain

Status

Recruiting

Address

Hospital General Universitario de Ciudad Real

Ciudad Real, , 13005

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Madrid, Spain

Status

Not yet recruiting

Address

Hospital General Universitario Gregorio Marañón

Madrid, , 28007

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario Ramon y Cajal, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario Ramon y Cajal

Madrid, , 28034

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario La Paz, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #42621

Hospital Universitario HM Sanchinarro, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario HM Sanchinarro

Madrid, , 28050

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario de Navarra, Pamplona, Spain

Status

Recruiting

Address

Hospital Universitario de Navarra

Pamplona, , 31008

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario Doctor Peset, Valencia, Spain

Status

Recruiting

Address

Hospital Universitario Doctor Peset

Valencia, , 46017

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

Hospital Universitario La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitario La Fe

Valencia, , 46026

Site Contact

Mercedes Dr Mitjavila Casanovas, MD-PhD

[email protected]

911916000 #46261

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