Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study.
Mercedes Mitjavila, Paula Jimenez-Fonseca, Pilar Belló...
https://pubmed.ncbi.nlm.nih.gov/36877234Actively Recruiting
Age: 18Years - 100Years
All Genders
ID04949282
SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177
Led by Sociedad Española de Medicina Nuclear e Imagen Molecular · Updated on 2022-12-23
5000
Participants Needed
20
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and analyzing clinical data from Spanish medical centers that have treated patients with the drug Lutetium [177Lu] oxodotreotide/dotatate to understand its effectiveness, tolerance, and safety in everyday medical practice. This research focuses on patients with various types of progressive, unresectable, or metastatic tumors that express somatostatin receptors. The study aims to learn about patient and tumor profiles and the outcomes achieved with this treatment. The study involves gathering patient information retrospectively from medical records after consent is obtained, without administering any new treatments as part of the research. The drug Lutetium [177Lu] oxodotreotide/dotatate is a radiopharmaceutical given by infusion, and data from its use in routine care will be pooled from different centers. This observational approach allows researchers to evaluate real-world results of the treatment. Participants' health data will be reviewed for up to 12 months to assess key outcomes such as progression-free survival, overall survival, and response rates. Additionally, researchers will examine adverse events, quality of life, prognostic factors, and areas where care can improve. The study does not involve active intervention but focuses on collecting and analyzing existing clinical information, with participation lasting according to data availability within the observation period.
CONDITIONS
Brief Title
Spanish Series of Patients Treated With the Radionuclide Lutetium177
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 618 years.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 12 months
Participants who have received Lutetium [177Lu] oxodotreotide/dotatate as part of their routine care are observed and their medical records are reviewed retrospectively.
Data collection from medical records; no additional visits required
Trial Site Locations
Total: 20 locations
1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
2
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain, 18014
Actively Recruiting
3
Hospital Unviersitari Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
Actively Recruiting
4
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Not Yet Recruiting
5
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Not Yet Recruiting
6
Hospital Univeritario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Not Yet Recruiting
7
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Actively Recruiting
8
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
9
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
10
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Not Yet Recruiting
11
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
12
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Actively Recruiting
13
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Not Yet Recruiting
14
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Not Yet Recruiting
15
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
16
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
17
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Not Yet Recruiting
18
Hospital Universitario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
19
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
Actively Recruiting
20
Hospital Universitario La Fe
Valencia, Spain, 46026
Actively Recruiting
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Research Team
M
Mercedes Dr Mitjavila Casanovas, MD-PhD
P
Paula Dr Jiménez Fonseca, MD-PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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