Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
Completed
Conditions studied: Neuroendocrine Tumor
In brief
This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \& Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment. The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first): 1. Date of death - the date at which a patient was reported in the database as having died 2. Last month active - the last recorded mention of the patient in the dataset 3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.
Key facts
- Study ID
- NCT05816720
- Run by
- Novartis Pharmaceuticals
- People needed
- 31
- Starts
- 2021-09-01
- Expected to finish
- 2022-01-31
- Last updated by the study team
- 2023-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of any NET
- Evidence of re-treatment with lutetium-177 DOTATATE
- Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE
- Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose
You may not qualify if…
- <18 years of age
Where it is running
- Excel Diagnostics & Nuclear Oncology Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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