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Lutathera safety under the microscope: 1,000+ patients monitored Long-Term

NCT ID NCT03691064

Knowledge-focused Sponsor: Advanced Accelerator Applications Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows over 1,000 adults with advanced neuroendocrine tumors who have already been treated with Lutathera. Researchers are tracking long-term side effects, including the risk of new cancers, and overall survival. The goal is to better understand the drug's safety over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,014 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroendocrine tumors

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Phoenix, Arizona, 85006, United States

  • Novartis Investigative site

    Clichy, France

  • Novartis Investigative site

    Lyon, France

  • Novartis Investigative site

    Villejuif, France

  • Novartis Investigative site

    Coimbra, Coimbra District, 3000-075, Portugal

  • Novartis Investigative site

    Santiago de Compostela, La Corunya, 15706, Spain

  • Novartis Investigative site

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative site

    Birmingham, B152WB, United Kingdom

  • Novartis Investigative site

    Cambridge, CB2 0QC, United Kingdom

  • Novartis Investigative site

    Glasgow, G12 OYN, United Kingdom

  • Novartis Investigative site

    Liverpool, L7 8XP, United Kingdom

  • Novartis Investigative site

    London, NW32QG, United Kingdom

  • Novartis Investigative site

    London, SE1 9RT, United Kingdom

  • Novartis Investigative site

    London, SE5 9RS, United Kingdom

  • Novartis Investigative site

    London, W6 8RF, United Kingdom

  • Novartis Investigative site

    Manchester, United Kingdom

  • Novartis Investigative site

    Sheffield, S102SJ, United Kingdom

  • Oregon Health & Sciences University Hospital

    Portland, Oregon, 97339, United States

  • The Ohio State University Wexner Medical Center

    Portland, Ohio, 43210, United States

  • Virginia Mason in Seattle

    Seattle, Washington, 98101, United States

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