NCT05816720

Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Lutetium-177 DOTATATE	Intravenous administration

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States