Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816720
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-01-30
Brief Title:
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE Lutathera
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE Lutathera
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 doses 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None