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LUTATHERA Injection General Use Result Survey

NCT ID: NCT05844332

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-17

Study Completion Date

2024-06-27

Brief Summary

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

Detailed Description

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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).

Conditions

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Somatostatin Receptor-positive Neuroendocrine Tumor

Keywords

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LUTATHERA

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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LUTATHERA

patients treated with LUTATHERA Injection

LUTATHERA

Intervention Type OTHER

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

Interventions

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LUTATHERA

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

Intervention Type OTHER

Other Intervention Names

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Lutetium oxodotreotide (177Lu)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Hirosaki, Aomori, Japan

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Kamogawa, Chiba, Japan

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Kashiwa, Chiba, Japan

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Tōon, Ehime, Japan

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Fukui-shi, Fukui, Japan

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Gifu, Gifu, Japan

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Maebashi, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kita-gun, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Kamakura, Kanagawa, Japan

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Yokohama, Kanagawa-ku, Japan

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Sendai, Miyagi, Japan

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Suwa, Nagano, Japan

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Niigata, Niigata, Japan

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Kurashiki, Okayama-ken, Japan

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Osaka, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Suita, Osaka, Japan

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Hamamatsu, Shizuoka, Japan

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Iwata, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Sunto Gun, Shizuoka, Japan

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Tokushima, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo Ku, Tokyo, Japan

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Koto Ku, Tokyo, Japan

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Toyama, Toyama, Japan

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Yamagata, Yamagata, Japan

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Chūō, Yamanashi, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Hiroshima, , Japan

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Kobe, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Okayama, , Japan

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Novartis Investigative Site

Osaka, , Japan

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Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18390

Link to study results

Other Identifiers

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CAAA601A11401

Identifier Type: -

Identifier Source: org_study_id