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LUTATHERA safety checked in 347 patients after market approval

NCT ID NCT05844332

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

347 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2024

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

All patients treated with this drug for the following indications during a certain post-marketing period • Indication: Somatostatin receptor-positive neuroendocrine tumor

Ages

18 to 99 years

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: * 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

  • 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

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