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NCT04727723: REAL-LU
Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
trial testing Lutathera® in Gastroenteropancreatic Neuroendocrine Tumor in 164 participants. Participants enrolled and being followed up; not accepting new ones.
31 March 2026
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 164 |
| Start date | 9 March 2021 |
| Primary completion | 31 March 2026 |
| Estimated completion | 31 March 2026 |
| Sites | 18 locations across Italy |
Drugs / interventions tested
- Lutathera®
Conditions studied
- Gastroenteropancreatic Neuroendocrine Tumor — all drugs for Gastroenteropancreatic Neuroendocrine Tumor →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, any sex, with Gastroenteropancreatic Neuroendocrine Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
[<sup>177</sup>Lu]Lu-DOTA-TATE versus standard of care in adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs): a cost-consequence analysis from an Italian hospital perspective.
Spada F, Campana D, Lamberti G, Laudicella R, et al · · 2022 · cited 11× · PMID 34950969 · DOI 10.1007/s00259-021-05656-x -
An Update of G-Protein-Coupled Receptor Signaling and Its Deregulation in Gastric Carcinogenesis.
Yan H, Zhang JL, Leung KT, Lo KW, et al · · 2023 · cited 8× · PMID 36765694 · DOI 10.3390/cancers15030736 -
The road to overcome pancreatic cancer: Where are we?
Tirpe A, Streianu C, Isachesku E, Simon I, et al · · 2024 · cited 6× · PMID 39403527 · DOI 10.1016/j.heliyon.2024.e38196 -
Lutetium [<sup>177</sup>Lu]-DOTA-TATE in gastroenteropancreatic-neuroendocrine tumours: rationale, design and baseline characteristics of the Italian prospective observational (REAL-LU) study.
Lastoria S, Rodari M, Sansovini M, Baldari S, et al · · 2024 · cited 4× · PMID 38772998 · DOI 10.1007/s00259-024-06725-7
Verify or expand the search:
- PubMed search for NCT04727723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroenteropancreatic Neuroendocrine Tumor
Currently open trials in the same condition.
- NCT04090034 — Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors · recruiting
- NCT06256705 — Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionucl · NA · recruiting
- NCT05636618 — Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors · Phase 1, PHASE2 · recruiting
- NCT06155318 — 68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04727723 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04727723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing