Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutathera® | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Lutathera®
- description
- Lutathera® will be administered according to the local label and according to the recommended treatment regimen in adults consisting of four equally divided doses of Lutathera® for a total of 29.6 GBq (800 mCi).
- interventionNames
- Drug: Lutathera®
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Up to 48 months
- description
- PFS, defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.
Secondary outcomes (29)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be obtained prior to any data collection. * Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET). * Aged ≥18 years. * Patients must be naïve to treatment with Lutathera® at enrolment. Exclusion Criteria: * Participation in a current or prior investigational study within 30 days preceding enrolment or within 5 half-lives of the investigational product, whichever is longer.
References
Publications (1)
- DERIVEDLastoria S, Rodari M, Sansovini M, Baldari S, D'Agostini A, Cervino AR, Filice A, Salgarello M, Perotti G, Nieri A, Campana D, Pellerito RE, Pomposelli E, Gaudieri V, Storto G, Grana CM, Signore A, Boni G, Dondi F, Simontacchi G, Seregni E. Lutetium [177Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective observational (REAL-LU) study. Eur J Nucl Med Mol Imaging. 2024 Sep;51(11):3417-3427. doi: 10.1007/s00259-024-06725-7. Epub 2024 May 22. PMID 38772998