Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
REAL-LU
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
1 other identifier
observational
164
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
March 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2026
CompletedMay 4, 2026
April 1, 2026
5 years
November 20, 2020
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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.
Up to 48 months
Secondary Outcomes (29)
Objective Response Rate (ORR)
Up to 48 months
Duration of Response (DoR), for those patients who achieve a best response of PR or better
Up to 48 months
Clinical Benefit Rate (CBR)
Up to 48 months
Duration of Clinical Benefit, for those patients who achieve a best response of SD or better
Up to 48 months
Time to Progression (TTP)
Up to 48 months
- +24 more secondary outcomes
Study Arms (1)
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).
Interventions
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
The study plans to enroll patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Novartis Investigative Site
Negrar, Italy
Novartis Investigative Site
Padova, 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
Related Publications (1)
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.
PMID: 38772998DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2020
First Posted
January 27, 2021
Study Start
March 9, 2021
Primary Completion
March 10, 2026
Study Completion
March 10, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share