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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: Completed study, sponsored by Novartis Pharmaceuticals.

NCT05816720 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death

Interventions

  • DRUG Lutetium-177 DOTATATE

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2021-09-01
Est. Completion 2022-01-31
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT05816720 record still lists

NCT05816720 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Lutetium-177 DOTATATE is the first listed.

NCT05816720 does not publish any study locations in the registry export this page uses.

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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Source: ClinicalTrials.gov NCT05816720, the US trial registry maintained by the National Library of Medicine. NCT05816720 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.