Pooling clinical experiences of patients treated with Lutetium-177 in Spain
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
This study looks at how well Lutetium-177 works and how safe it is for patients with certain types of tumors in Spain by collecting information from their medical records.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sociedad Española de Medicina Nuclear e Imagen Molecular Academic / other |
| Locations | 20 sites (Santiago de Compostela, A Coruña and 19 other locations) |
| Trial ID | NCT04949282 on ClinicalTrials.gov |
What this trial studies
This observational study collects and analyzes data from Spanish medical centers treating patients with somatostatin receptor positive tumors using Lutetium-177. The aim is to evaluate the efficacy, safety, and tolerance of this treatment in routine clinical practice. Patient data will be gathered retrospectively from medical records after obtaining informed consent, focusing on the profiles of patients and tumors treated. The study will provide insights into treatment outcomes across various types of neuroendocrine tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with unresectable or metastatic, progressive somatostatin receptor positive tumors.
Not a fit: Patients with resectable tumors or those who do not have somatostatin receptor positive tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of Lutetium-177's effectiveness and safety, potentially improving treatment strategies for patients with neuroendocrine tumors.
How similar studies have performed: Other studies have shown promising results with Lutetium-177 in treating similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full 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
Where this trial is running
Santiago de Compostela, A Coruña and 19 other locations
- Hospital Clínico Universitario de Santiago — Santiago de Compostela, A Coruña, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves — Granada, Andalusia, Spain (Recruiting)
- Hospital Unviersitari Son Espases — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario de Getafe — Getafe, Madrid, Spain (Not_yet_recruiting)
- Hospital Univeritario Puerta de Hierro — Majadahonda, Madrid, Spain (Not_yet_recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Clínica Universidad de Navarra — Pamplona, Navarre, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario de Burgos — Burgos, Spain (Recruiting)
- Hospital General Universitario de Ciudad Real — Ciudad Real, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario HM Sanchinarro — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital Universitario Doctor Peset — Valencia, Spain (Recruiting)
- Hospital Universitario La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Mercedes Dr Mitjavila Casanovas, MD-PhD — Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)
- Study coordinator: Mercedes Dr Mitjavila Casanovas, MD-PhD
- Email: mercedes.mitjavila@salud.madrid.org
- Phone: 911916000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.