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Spots Global Cancer Trial Database for Post-Authorization Long-Term Safety Study of LUTATHERA

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Trial Identification

Brief Title: Post-Authorization Long-Term Safety Study of LUTATHERA

Official Title: International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

Study ID: NCT03691064

Interventions

LUTATHERA

Study Description

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

Detailed Description: To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Banner MD Anderson Cancer Center, Phoenix, Arizona, United States

The Ohio State University Wexner Medical Center, Portland, Ohio, United States

Oregon Health & Sciences University Hospital, Portland, Oregon, United States

Virginia Mason in Seattle, Seattle, Washington, United States

Novartis Investigative site, Clichy, , France

Novartis Investigative site, Lyon, , France

Novartis Investigative site, Villejuif, , France

Novartis Investigative site, Coimbra, , Portugal

Novartis Investigative site, Santiago de Compostela, La Corunya, Spain

Novartis Investigative site, Majadahonda, Madrid, Spain

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, Scheffield, , United Kingdom

Contact Details

Name: Study Director

Affiliation: Advanced Accelerator Applications

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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