NCT04727723

Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Gastroenteropancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	Lutathera®	Treatment with Lutathera® will be independent from participation in this observational study and must not be initiated for the purpose of participating in this study. The decision to treat patients with Lutathera® will occur before patients are enrolled in the study.

Timeline

• Start date: 2021-03-09
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2021-01-27
• Last updated: 2026-03-20

Locations

18 sites across 1 country: Italy