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/36877234/Actively Recruiting
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
Researchers are collecting and analyzing clinical data from Spanish medical centers that have treated patients with the drug Lutetium 177Lu oxodotreotidedotatate 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 oxodotreotidedotatate 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
Spanish Series of Patients Treated With the Radionuclide Lutetium177
M
Mercedes Dr Mitjavila Casanovas, MD-PhD
P
Paula Dr Jiménez Fonseca, MD-PhD
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Sociedad Española de Medicina Nuclear e Imagen Molecular
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Mercedes Mitjavila, Paula Jimenez-Fonseca, Pilar Belló...
https://pubmed.ncbi.nlm.nih.gov/36877234/Sociedad Española de Medicina Nuclear e Imagen Molecular
Lead Sponsor