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NCT05816720 · ClinicalTrials.gov registry record
Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 31
- Enrollment target
NCT05816720 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants.
The verdict
NCT05816720 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study 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.
Interventions
- DRUG Lutetium-177 DOTATATE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2022-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05816720
The ClinicalTrials.gov registry entry for NCT05816720 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lutetium-177 DOTATATE is the first listed.
NCT05816720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05816720 about?
NCT05816720 is a clinical study titled "Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)". 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...
What is the current status of trial NCT05816720?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2021-09-01. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT05816720?
The interventions under investigation include: Lutetium-177 DOTATATE (DRUG).
Who is sponsoring clinical trial NCT05816720?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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