LUTATHERA Injection General Use Result Survey

December 15, 2025 updated by: Novartis Pharmaceuticals

LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)

This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

For patients who discontinue treatment with this drug during the observation period, necessary variables were examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).

Study Type

Observational

Enrollment (Actual)

347

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8717
        • Novartis Investigative Site
      • Fukuoka, Japan, 814-0001
        • Novartis Investigative Site
      • Fukuoka, Japan, 8128582
        • Novartis Investigative Site
      • Fukushima, Japan, 960 1295
        • Novartis Investigative Site
      • Hiroshima, Japan, 7348551
        • Novartis Investigative Site
      • Kobe, Japan, 650-0017
        • Novartis Investigative Site
      • Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
      • Kyoto, Japan, 606 8507
        • Novartis Investigative Site
      • Okayama, Japan, 7008558
        • Novartis Investigative Site
      • Osaka, Japan, 5458586
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464 8681
        • Novartis Investigative Site
    • Aomori
      • Hirosaki, Aomori, Japan, 036 8563
        • Novartis Investigative Site
    • Chiba
      • Kamogawa, Chiba, Japan, 296-8602
        • Novartis Investigative Site
      • Kashiwa, Chiba, Japan, 277 8577
        • Novartis Investigative Site
    • Ehime
      • Tōon, Ehime, Japan, 7910295
        • Novartis Investigative Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-8526
        • Novartis Investigative Site
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Novartis Investigative Site
    • Gunma
      • Maebashi, Gunma, Japan, 371 8511
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060 8648
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 608543
        • Novartis Investigative Site
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 6500047
        • Novartis Investigative Site
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920 8641
        • Novartis Investigative Site
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 7610793
        • Novartis Investigative Site
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890 8520
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
        • Novartis Investigative Site
    • Kanagawa-ku
      • Yokohama, Kanagawa-ku, Japan, 236-0004
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 980 8574
        • Novartis Investigative Site
    • Nagano
      • Suwa, Nagano, Japan, 392-8510
        • Novartis Investigative Site
    • Niigata
      • Niigata, Niigata, Japan, 951-8566
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 7108602
        • Novartis Investigative Site
    • Osaka
      • Osaka, Osaka, Japan, 5418567
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 553-0003
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 590-0197
        • Novartis Investigative Site
      • Suita, Osaka, Japan, 565 0871
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 4313192
        • Novartis Investigative Site
      • Iwata, Shizuoka, Japan, 438-8550
        • Novartis Investigative Site
      • Shizuoka, Shizuoka, Japan, 420-8527
        • Novartis Investigative Site
      • Sunto Gun, Shizuoka, Japan, 411 8777
        • Novartis Investigative Site
    • Tokushima
      • Tokushima, Tokushima, Japan, 7708503
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Novartis Investigative Site
      • Chuo Ku, Tokyo, Japan, 104 0045
        • Novartis Investigative Site
      • Koto Ku, Tokyo, Japan, 135 8550
        • Novartis Investigative Site
    • Toyama
      • Toyama, Toyama, Japan, 9300194
        • Novartis Investigative Site
    • Yamagata
      • Yamagata, Yamagata, Japan, 990 9585
        • Novartis Investigative Site
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients treated with this drug for the following indications during a certain post-marketing period

• Indication: Somatostatin receptor-positive neuroendocrine tumor

Description

Inclusion Criteria:

  • All patients treated with this drug for the following indications during a certain post-marketing period

    • Indication: Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. Patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug.

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LUTATHERA
patients treated with LUTATHERA Injection
Other: LUTATHERA
There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.
Other Names:
  • Lutetium oxodotreotide (177Lu)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises
Time Frame: Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).
To evaluate the safety about Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises after administration of this drug in a real world setting
Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Actual)

June 27, 2024

Study Completion (Actual)

June 27, 2024

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAA601A11401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Somatostatin Receptor-positive Neuroendocrine Tumor

Clinical Trials on LUTATHERA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe