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.
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
- Conditions the study is for
- Somatostatin Receptor-positive Neuroendocrine Tumor
- 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
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 group | Role | What they receive |
|---|---|---|
| LUTATHERA | patients treated with LUTATHERA Injection Receives: Other: LUTATHERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted6 May 2023
- Study start17 Dec 2021
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatostatin Receptor-positive Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)
- ClinicalTrials.gov ID
- NCT05844332
- Acronym / sponsor ID
- CAAA601A11401
- Keywords
- LUTATHERA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUTATHERA | – | Other: LUTATHERApatients treated with LUTATHERA Injection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- All patients treated with this drug for the following indications during a certain post-marketing period
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUTATHERAAlso: Lutetium oxodotreotide (177Lu)There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled. | Other | LUTATHERA |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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RecruitingPhase 1/2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
46 sites in 1 country: see every site and its status.
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.