Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
NCT ID: NCT04727723
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
164 participants
OBSERVATIONAL
2021-03-09
2026-03-31
Brief Summary
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Detailed Description
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The study duration will be 48 months in total: 12 months recruitment and 36 of follow-up from the last patient in.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lutathera®
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Advanced Accelerator Applications
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Napoli, , Italy
Novartis Investigative Site
Negrar, , Italy
Novartis Investigative Site
Padua, , Italy
Novartis Investigative Site
Pisa, , Italy
Novartis Investigative Site
Reggio Emilia, , Italy
Novartis Investigative Site
Rionero in Volture, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
Rozzano, , Italy
Novartis Investigative Site
Torino, , Italy
Countries
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References
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Lastoria 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.
Other Identifiers
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CAAA601A0IT02
Identifier Type: -
Identifier Source: org_study_id
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