NCT04949282 (SEPTRALU) is a clinical trial of Lutetium [177Lu] oxodotreotide/dotatate in Neuroendocrine Tumors, sponsored by Sociedad Española de Medicina Nuclear e Imagen Molecular.

Who is sponsoring NCT04949282?

NCT04949282 is sponsored by Sociedad Española de Medicina Nuclear e Imagen Molecular.

What drugs are being tested in NCT04949282?

Interventions in NCT04949282: Lutetium [177Lu] oxodotreotide/dotatate, Lutetium [177Lu] oxodotreotide/dotatate.

What condition does NCT04949282 study?

NCT04949282 studies Neuroendocrine Tumors, Intestinal Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Nerve Tissue, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Endocrine Gland Neoplasms, Digestive System Diseases, Gastrointestinal Disease, Intestinal Diseases, Pancreatic Disease, Endocrine System Diseases.

Is NCT04949282 still recruiting?

NCT04949282 is currently recruiting now. Last updated 23 December 2022.

Last reviewed 2022-12-23 · How we verify

NCT04949282: SEPTRALU

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Spanish Series of Patients Treated With the Radionuclide Lutetium177

Recruiting now Last updated 23 December 2022

What this trial tests

trial testing Lutetium [177Lu] oxodotreotide/dotatate in Neuroendocrine Tumors in 5,000 participants. Currently enrolling.

Timeline

10 May 2021

Primary endpoint
31 December 2034

31 December 2035

Quick facts

Lead sponsor	Sociedad Española de Medicina Nuclear e Imagen Molecular
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	10 May 2021
Primary completion	31 December 2034
Estimated completion	31 December 2035
Sites	20 locations across Spain

Drugs / interventions tested

Lutetium [177Lu] oxodotreotide/dotatate — full drug profile →
Lutetium [177Lu] oxodotreotide/dotatate — full drug profile →

Conditions studied

Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
Intestinal Neoplasms — all drugs for Intestinal Neoplasms →
Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
Stomach Neoplasms — all drugs for Stomach Neoplasms →

Sponsor

Sociedad Española de Medicina Nuclear e Imagen Molecular

Who can join

Adults 18 to 100, any sex, with Neuroendocrine Tumors or Intestinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy of [177Lu]Lu-DOTATATE in metastatic neuroendocrine neoplasms of different locations: data from the SEPTRALU study.
Mitjavila M, Jimenez-Fonseca P, Belló P, Pubul V, et al · · 2023 · cited 35× · PMID 36877234 · DOI 10.1007/s00259-023-06166-8
Lutathera® Orphans: State of the Art and Future Application of Radioligand Therapy with 177Lu-DOTATATE.
Urso L, Nieri A, Uccelli L, Castello A, et al · · 2023 · cited 29× · PMID 37111596 · DOI 10.3390/pharmaceutics15041110
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

Verify or expand the search:

Other trials of Lutetium [177Lu] oxodotreotide/dotatate

Trials testing the same drug.

NCT04711135 — Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Phase 2 · active not recruiting

Other recruiting trials for Neuroendocrine Tumors

Currently open trials in the same condition.

NCT07404176 — Study to Assess the Safety and Effectiveness of Novel Radiopharmaceutical Terbium-161 DOTATATE in Metastatic Neuroendocr · Phase 2 · recruiting
NCT07314164 — Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment · recruiting
NCT07272512 — Prospective Multicenter Real-world Study of Surufatinib in Patients With Advanced Neuroendocrine Neoplasms · Phase 4 · recruiting
NCT06735560 — Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN · NA · recruiting
NCT06889493 — SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Dif · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04949282 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Sociedad Española de Medicina Nuclear e Imagen Molecular
Last refreshed: 23 December 2022

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/NCT04949282.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing