NCT03691064

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,014

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
5 countries

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2018Sep 2027

First Submitted

Initial submission to the registry

September 22, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

December 23, 2025

Status Verified

November 1, 2025

Enrollment Period

8.8 years

First QC Date

September 22, 2018

Last Update Submit

December 17, 2025

Conditions

Neuroendocrine Tumors

Keywords

Gastroenteropancreatic neuroendocrine tumours

Outcome Measures

Primary Outcomes (1)

  • secondary cancers: incidence of secondary cancers

    incidence of secondary cancers

    up to 7 years follow-up

Secondary Outcomes (5)

  • safety profile: incidence of adverse events

    up to 7 years follow-up

  • mortality

    up to 7 years follow-up

  • LUTATHERA dose per administration

    completion of treatment phase (approximately 2 years total)

  • LUTATHERA total dose

    completion of treatment phase (approximately 2 years total)

  • LUTATHERA number of administrations

    completion of treatment phase (approximately 2 years total)

Study Arms (1)

LUTATHERA

Treated per labeled LUTATHERA dosing regimen.

Drug: LUTATHERA

Interventions

LUTATHERADRUG

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

Also known as: Lu 177 dotatate
LUTATHERA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Banner MD Anderson Cancer Center

Phoenix, Arizona, 85006, United States

Location

The Ohio State University Wexner Medical Center

Portland, Ohio, 43210, United States

Location

Oregon Health & Sciences University Hospital

Portland, Oregon, 97339, United States

Location

Virginia Mason in Seattle

Seattle, Washington, 98101, United States

Location

Novartis Investigative site

Clichy, France

Location

Novartis Investigative site

Lyon, France

Location

Novartis Investigative site

Villejuif, France

Location

Novartis Investigative site

Coimbra, Coimbra District, 3000-075, Portugal

Location

Novartis Investigative site

Santiago de Compostela, La Corunya, 15706, Spain

Location

Novartis Investigative site

Majadahonda, Madrid, 28222, Spain

Location

Novartis Investigative site

Birmingham, B152WB, United Kingdom

Location

Novartis Investigative site

Cambridge, CB2 0QC, United Kingdom

Location

Novartis Investigative site

Glasgow, G12 OYN, United Kingdom

Location

Novartis Investigative site

Liverpool, L7 8XP, United Kingdom

Location

Novartis Investigative site

London, NW32QG, United Kingdom

Location

Novartis Investigative site

London, SE1 9RT, United Kingdom

Location

Novartis Investigative site

London, SE5 9RS, United Kingdom

Location

Novartis Investigative site

London, W6 8RF, United Kingdom

Location

Novartis Investigative site

Manchester, United Kingdom

Location

Novartis Investigative site

Sheffield, S102SJ, United Kingdom

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Study Director

    Advanced Accelerator Applications

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2018

First Posted

October 1, 2018

Study Start

November 28, 2018

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

December 23, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)FR(3)ES(2)PT(1)GB(10)