An observational study in Neuroendocrine Tumors, Intestinal Neoplasms and Pancreatic Neoplasms, sponsored by Sociedad Española de Medicina Nuclear e Imagen Molecular. Recruiting at 20 sites in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Sociedad Española de Medicina Nuclear e Imagen Molecular · Observational
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.
Patient data will be collected from medical records after obtaining consent and retrospectively.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 130 across 129 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →This is the only study on the registry with Sociedad Española de Medicina Nuclear e Imagen Molecular as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lutetium [177Lu] oxodotreotide/dotatate · Device: Lutetium [177Lu] oxodotreotide/dotatate
Drug page: Lutetium-177
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Also known as: Lutathera
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Also known as: Lutathera
Progression Free Survival (PFS)
Defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.
Time frame: Up to 12 months
Overall survival (OS)
Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Time frame: Up to 12 months
Overall response rate (ORR)
Is determined by imaging technique according to RECIST criteria v1.1 and is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1
Time frame: Up to 12 months
Characteristics of the population .
Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.
Time frame: Up to 12 months
Adverse Events (AEs)
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
Time frame: Up to 12 months
Prognostic factors
Correlation of possible prognostic factors with clinical effectiveness outcomes.
Time frame: Up to 12 months
Areas for improvement care
Identification of areas for improvement in the management and selection of patients for treatment with lutathera
Time frame: Up to 12 months
Health-related Quality of Life (HRQoL)
Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire.The minimum value ( 1%) and the maximum value (100%), and higher scores mean a better outcome.
Time frame: Up to 12 months
Started May 2021 (actual). Primary completion is estimated for Dec 2034, 163 months after the start.
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