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Post-Authorization Long-Term Safety Study of LUTATHERA

NCT ID: NCT03691064

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-28

Study Completion Date

2027-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuroendocrine Tumors

Keywords

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Gastroenteropancreatic neuroendocrine tumours

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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LUTATHERA

Treated per labeled LUTATHERA dosing regimen.

LUTATHERA

Intervention Type DRUG

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

Interventions

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LUTATHERA

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

Intervention Type DRUG

Other Intervention Names

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Lu 177 dotatate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Accelerator Applications

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Advanced Accelerator Applications

Locations

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Banner MD Anderson Cancer Center

Phoenix, Arizona, United States

Site Status

The Ohio State University Wexner Medical Center

Portland, Ohio, United States

Site Status

Oregon Health & Sciences University Hospital

Portland, Oregon, United States

Site Status

Virginia Mason in Seattle

Seattle, Washington, United States

Site Status

Novartis Investigative site

Clichy, , France

Site Status

Novartis Investigative site

Lyon, , France

Site Status

Novartis Investigative site

Villejuif, , France

Site Status

Novartis Investigative site

Coimbra, Coimbra District, Portugal

Site Status

Novartis Investigative site

Santiago de Compostela, La Corunya, Spain

Site Status

Novartis Investigative site

Majadahonda, Madrid, Spain

Site Status

Novartis Investigative site

Birmingham, , United Kingdom

Site Status

Novartis Investigative site

Cambridge, , United Kingdom

Site Status

Novartis Investigative site

Glasgow, , United Kingdom

Site Status

Novartis Investigative site

Liverpool, , United Kingdom

Site Status

Novartis Investigative site

London, , United Kingdom

Site Status

Novartis Investigative site

London, , United Kingdom

Site Status

Novartis Investigative site

London, , United Kingdom

Site Status

Novartis Investigative site

London, , United Kingdom

Site Status

Novartis Investigative site

Manchester, , United Kingdom

Site Status

Novartis Investigative site

Sheffield, , United Kingdom

Site Status

Countries

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United States France Portugal Spain United Kingdom

Other Identifiers

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CAAA601A12402

Identifier Type: OTHER

Identifier Source: secondary_id

EUPAS25735

Identifier Type: OTHER

Identifier Source: secondary_id

A-LUT-T-E02-402

Identifier Type: -

Identifier Source: org_study_id