Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, 77042, United States
NCT Number: NCT05816720
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.
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Notify Me18 year and older
All sexes
Observational
Houston, Texas, 77042, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous administration
Other names: Lutathera®
Time frame: Up to approximately 11 years
Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death
Time frame: Up to approximately 11 years
Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death
Time frame: Up to approximately 11 years
Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD)
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Prior to initial treatment with lutetium-177 DOTATATE
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Time frame: Up to approximately 11 years
Novartis Pharmaceuticals
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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