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Somatostatin Receptor-positive Neuroendocrine TumorNCT05844332

LUTATHERA Injection General Use Result Survey

An observational study of Somatostatin Receptor-positive Neuroendocrine Tumor, run by Novartis Pharmaceuticals at 46 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 99 years
What is being tested?
LUTATHERA
Type of treatment
Injection or infusion
How many people
347 participants
Where
46 sitesJapan
Study dates
17 Dec 2021to 27 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Not applicable

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Japan46 sites
  • Novartis Investigative Site

    Akashi, Hyōgo, 673-8558

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 1138519

  • Novartis Investigative Site

    Chiba, 260-8717

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104 0045

  • Novartis Investigative Site

    Fukui-shi, Fukui, 910-8526

  • Novartis Investigative Site

    Fukuoka, 8128582

  • Novartis Investigative Site

    Fukuoka, 814-0001

  • Novartis Investigative Site

    Fukushima, 960 1295

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 4313192

  • Novartis Investigative Site

    Hirosaki, Aomori, 036 8563

  • Novartis Investigative Site

    Hiroshima, 7348551

  • Novartis Investigative Site

    Iwata, Shizuoka, 438-8550

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890 8520

  • Novartis Investigative Site

    Kamakura, Kanagawa, 247-8533

  • Novartis Investigative Site

    Kamogawa, Chiba, 296-8602

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920 8641

  • Novartis Investigative Site

    Kashiwa, Chiba, 277 8577

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 7610793

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047

  • Novartis Investigative Site

    Kobe, 650-0017

  • Novartis Investigative Site

    Koto Ku, Tokyo, 135 8550

  • Novartis Investigative Site

    Kumamoto, 860-8556

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 7108602

  • Novartis Investigative Site

    Kyoto, 606 8507

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681

  • Novartis Investigative Site

    Niigata, Niigata, 951-8566

  • Novartis Investigative Site

    Okayama, 7008558

  • Novartis Investigative Site

    Osaka, Osaka, 5418567

  • Novartis Investigative Site

    Osaka, Osaka, 553-0003

  • Novartis Investigative Site

    Osaka, 5458586

  • Novartis Investigative Site

    Sakai, Osaka, 590-0197

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648

  • Novartis Investigative Site

    Sapporo, Hokkaido, 608543

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

  • Novartis Investigative Site

    Shizuoka, Shizuoka, 420-8527

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Sunto Gun, Shizuoka, 411 8777

  • Novartis Investigative Site

    Suwa, Nagano, 392-8510

  • Novartis Investigative Site

    Tokushima, Tokushima, 7708503

  • Novartis Investigative Site

    Tōon, Ehime, 7910295

  • Novartis Investigative Site

    Toyama, Toyama, 9300194

  • Novartis Investigative Site

    Yamagata, Yamagata, 990 9585

  • Novartis Investigative Site

    Yokohama, Kanagawa-ku, 236-0004

Other trials in Japan

About this study

Official title: 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.

Read the 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).

Being tested
LUTATHERA
Keywords
LUTATHERA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUTATHERAOther

    Also called Lutetium oxodotreotide (177Lu)

    There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.

Study groups in NCT05844332
Study groupRoleWhat they receive
LUTATHERApatients treated with LUTATHERA Injection
Receives: Other: LUTATHERA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start17 Dec 2021
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844332
Sponsor's protocol ID
CAAA601A11401
Status last verified
Dec 2025
First submitted
25 Apr 2023
Last updated
22 Dec 2025
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Somatostatin Receptor-positive Neuroendocrine Tumor, run by Novartis Pharmaceuticals at 46 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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