LUTATHERA Injection General Use Result Survey
1 other identifier
observational
347
1 country
46
Brief Summary
This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Typical duration for all trials
46 active sites
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 Start
First participant enrolled
December 17, 2021
CompletedFirst Submitted
Initial submission to the registry
April 25, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedDecember 22, 2025
December 1, 2025
2.5 years
April 25, 2023
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises
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).
Study Arms (1)
LUTATHERA
patients treated with LUTATHERA Injection
Interventions
There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.
Eligibility Criteria
All patients treated with this drug for the following indications during a certain post-marketing period • Indication: Somatostatin receptor-positive neuroendocrine tumor
You may qualify if:
- 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.
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Novartis Investigative Site
Nagoya, Aichi-ken, 464 8681, Japan
Novartis Investigative Site
Hirosaki, Aomori, 036 8563, Japan
Novartis Investigative Site
Kamogawa, Chiba, 296-8602, Japan
Novartis Investigative Site
Kashiwa, Chiba, 277 8577, Japan
Novartis Investigative Site
Tōon, Ehime, 7910295, Japan
Novartis Investigative Site
Fukui-shi, Fukui, 910-8526, Japan
Novartis Investigative Site
Gifu, Gifu, 501-1194, Japan
Novartis Investigative Site
Maebashi, Gunma, 371 8511, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 608543, Japan
Novartis Investigative Site
Akashi, Hyōgo, 673-8558, Japan
Novartis Investigative Site
Kobe, Hyōgo, 6500047, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8641, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, 7610793, Japan
Novartis Investigative Site
Kagoshima, Kagoshima-ken, 890 8520, Japan
Novartis Investigative Site
Kamakura, Kanagawa, 247-8533, Japan
Novartis Investigative Site
Yokohama, Kanagawa-ku, 236-0004, Japan
Novartis Investigative Site
Sendai, Miyagi, 980 8574, Japan
Novartis Investigative Site
Suwa, Nagano, 392-8510, Japan
Novartis Investigative Site
Niigata, Niigata, 951-8566, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, 7108602, Japan
Novartis Investigative Site
Osaka, Osaka, 5418567, Japan
Novartis Investigative Site
Osaka, Osaka, 553-0003, Japan
Novartis Investigative Site
Sakai, Osaka, 590-0197, Japan
Novartis Investigative Site
Suita, Osaka, 565 0871, Japan
Novartis Investigative Site
Hamamatsu, Shizuoka, 4313192, Japan
Novartis Investigative Site
Iwata, Shizuoka, 438-8550, Japan
Novartis Investigative Site
Shizuoka, Shizuoka, 420-8527, Japan
Novartis Investigative Site
Sunto Gun, Shizuoka, 411 8777, Japan
Novartis Investigative Site
Tokushima, Tokushima, 7708503, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045, Japan
Novartis Investigative Site
Koto Ku, Tokyo, 135 8550, Japan
Novartis Investigative Site
Toyama, Toyama, 9300194, Japan
Novartis Investigative Site
Yamagata, Yamagata, 990 9585, Japan
Novartis Investigative Site
Chūō, Yamanashi, 409-3898, Japan
Novartis Investigative Site
Chiba, 260-8717, Japan
Novartis Investigative Site
Fukuoka, 8128582, Japan
Novartis Investigative Site
Fukuoka, 814-0001, Japan
Novartis Investigative Site
Fukushima, 960 1295, Japan
Novartis Investigative Site
Hiroshima, 7348551, Japan
Novartis Investigative Site
Kobe, 650-0017, Japan
Novartis Investigative Site
Kumamoto, 860-8556, Japan
Novartis Investigative Site
Kyoto, 606 8507, Japan
Novartis Investigative Site
Okayama, 7008558, Japan
Novartis Investigative Site
Osaka, 5458586, Japan
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
May 6, 2023
Study Start
December 17, 2021
Primary Completion
June 27, 2024
Study Completion
June 27, 2024
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share