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Two Steps Italian Prospective obsErvationAL Study Assessing the Effectiveness and Outcomes Associated With LUtathera (177Lu) Oxodotreotide Treatment in Adult Subjects With Unresectable or Metastatic, Progressive, Well Differentiated (G1 and G2), Somatostatin Receptor Positive Gastroenteropancreatic-neuroendocrine Tumours (GEP-NETs) - REAL-LU
This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs who have been prescribed Lutathera® in standard clinical practice.
Data on patients will be collected from the date when patient consent was obtained, during treatment with Lutathera® and for a follow-up period until end of study (EOS), defined as the time when the last enrolled patient has completed 36 months of assessments (unless early termination) after enrolment. Data will be collected in accordance with routine clinical visits. The study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Alessandria, Italy
Novartis Investigative Site
Bologna, Italy
Novartis Investigative Site
Brescia, Italy
Novartis Investigative Site
Cona, Italy
Novartis Investigative Site
Florence, Italy
Novartis Investigative Site
Latina, Italy
Novartis Investigative Site
Meldola, Italy
Novartis Investigative Site
Messina, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Naples, Italy
Start Date
March 9, 2021
Primary Completion Date
March 31, 2026
Completion Date
March 31, 2026
Last Updated
March 20, 2026
164
ACTUAL participants
Lutathera®
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06790706
NCT01842165
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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