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Clinical Trials in France / NCT03691064
Active, not recruiting Observational

Post-Authorization Long-Term Safety Study of LUTATHERA

NCT03691064 · tracked via the Priya Life Science France tracker
Sponsor
Advanced Accelerator Applications
Phase
Observational
Started
2018-11-28
Last updated
2025-12-23

Condition(s) studied

Neuroendocrine Tumors

Investigational drug(s) / intervention(s)

LUTATHERA →

LUTATHERA: Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie \[mCi\]) every 8 weeks for a total of 4 doses.

Study summary

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * adult patients (fulfilling the definition of "age of majority" per local regulations), * with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs * and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending). Exclusion Criteria: * Hypersensitivity to Lutathera (active substance or any of the excipients), * presence of established or suspected pregnancy or pregnancy not excluded, * presence of kidney failure with creatinine clearance \< 30 mL/min.

Primary outcome measure(s)

  • secondary cancers: incidence of secondary cancers — up to 7 years follow-up
    incidence of secondary cancers

Trial sites (20)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Phoenix Arizona
The Ohio State University Wexner Medical Center Portland Ohio
Oregon Health & Sciences University Hospital Portland Oregon
Virginia Mason in Seattle Seattle Washington
Novartis Investigative site Clichy France
Novartis Investigative site Lyon France
Novartis Investigative site Villejuif France
Novartis Investigative site Coimbra Coimbra District
Novartis Investigative site Santiago de Compostela La Corunya
Novartis Investigative site Majadahonda Madrid
Novartis Investigative site Birmingham United Kingdom
Novartis Investigative site Cambridge United Kingdom
Novartis Investigative site Glasgow United Kingdom
Novartis Investigative site Liverpool United Kingdom
Novartis Investigative site London United Kingdom
Novartis Investigative site London United Kingdom
Novartis Investigative site London United Kingdom
Novartis Investigative site London United Kingdom
Novartis Investigative site Manchester United Kingdom
Novartis Investigative site Sheffield United Kingdom

More Advanced Accelerator Applications trials in France

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs Active, not recruiting
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET Active, not recruiting

Other trials for the same condition

Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department Recruiting
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET Recruiting
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients Active, not recruiting
Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma Active, not recruiting
Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an MEN1 Mutation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03691064 on ClinicalTrials.gov ↗ ← All trials in France