LUTATHERA safety checked in 347 patients after market approval
NCT ID NCT05844332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the real-world safety of LUTATHERA, a radioactive drug used to treat a type of nerve and hormone cell cancer called neuroendocrine tumors. Researchers tracked 347 patients who received the drug in regular medical practice, focusing on kidney problems, bone marrow issues, and other serious side effects. The goal was to gather safety information outside of clinical trials to help guide future use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LUTATHERA (lutetium oxodotreotide)
- What this could lead to
- If successful, this study will provide real-world safety data on LUTATHERA, helping doctors better understand and manage risks like kidney problems and blood disorders in patients with neuroendocrine tumors.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and other treatments. The study is completed, but findings may not change current practice.
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
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347 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Jun 2024
- Lead sponsor
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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
All patients treated with this drug for the following indications during a certain post-marketing period • Indication: Somatostatin receptor-positive neuroendocrine tumor
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis Investigative Site
Nagoya, Aichi-ken, 464 8681, Japan
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Novartis Investigative Site
Hirosaki, Aomori, 036 8563, Japan
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Novartis Investigative Site
Kamogawa, Chiba, 296-8602, Japan
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Novartis Investigative Site
Kashiwa, Chiba, 277 8577, Japan
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Novartis Investigative Site
Tōon, Ehime, 7910295, Japan
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Novartis Investigative Site
Fukui-shi, Fukui, 910-8526, Japan
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Novartis Investigative Site
Gifu, Gifu, 501-1194, Japan
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Novartis Investigative Site
Maebashi, Gunma, 371 8511, Japan
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Novartis Investigative Site
Sapporo, Hokkaido, 060 8648, Japan
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Novartis Investigative Site
Sapporo, Hokkaido, 608543, Japan
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Novartis Investigative Site
Akashi, Hyōgo, 673-8558, Japan
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Novartis Investigative Site
Kobe, Hyōgo, 6500047, Japan
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Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8641, Japan
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Novartis Investigative Site
Kita-gun, Kagawa-ken, 7610793, Japan
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Novartis Investigative Site
Kagoshima, Kagoshima-ken, 890 8520, Japan
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Novartis Investigative Site
Kamakura, Kanagawa, 247-8533, Japan
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Novartis Investigative Site
Yokohama, Kanagawa-ku, 236-0004, Japan
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Novartis Investigative Site
Sendai, Miyagi, 980 8574, Japan
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Novartis Investigative Site
Suwa, Nagano, 392-8510, Japan
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Novartis Investigative Site
Niigata, Niigata, 951-8566, Japan
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Novartis Investigative Site
Kurashiki, Okayama-ken, 7108602, Japan
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Novartis Investigative Site
Osaka, Osaka, 5418567, Japan
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Novartis Investigative Site
Osaka, Osaka, 553-0003, Japan
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Novartis Investigative Site
Sakai, Osaka, 590-0197, Japan
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Novartis Investigative Site
Suita, Osaka, 565 0871, Japan
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Novartis Investigative Site
Hamamatsu, Shizuoka, 4313192, Japan
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Novartis Investigative Site
Iwata, Shizuoka, 438-8550, Japan
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Novartis Investigative Site
Shizuoka, Shizuoka, 420-8527, Japan
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Novartis Investigative Site
Sunto Gun, Shizuoka, 411 8777, Japan
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Novartis Investigative Site
Tokushima, Tokushima, 7708503, Japan
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Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519, Japan
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Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045, Japan
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Novartis Investigative Site
Koto Ku, Tokyo, 135 8550, Japan
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Novartis Investigative Site
Toyama, Toyama, 9300194, Japan
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Novartis Investigative Site
Yamagata, Yamagata, 990 9585, Japan
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Novartis Investigative Site
Chūō, Yamanashi, 409-3898, Japan
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Novartis Investigative Site
Chiba, 260-8717, Japan
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Novartis Investigative Site
Fukuoka, 8128582, Japan
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Novartis Investigative Site
Fukuoka, 814-0001, Japan
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Novartis Investigative Site
Fukushima, 960 1295, Japan
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Novartis Investigative Site
Hiroshima, 7348551, Japan
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Novartis Investigative Site
Kobe, 650-0017, Japan
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Novartis Investigative Site
Kumamoto, 860-8556, Japan
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Novartis Investigative Site
Kyoto, 606 8507, Japan
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Novartis Investigative Site
Okayama, 7008558, Japan
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Novartis Investigative Site
Osaka, 5458586, Japan
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