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Completed

NCT Number: NCT05844332

LUTATHERA Injection General Use Result Survey

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

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Key information

Conditions

Somatostatin Receptor-positive Neuroendocrine Tumor

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUTATHERA

Other

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

Other names: Lutetium oxodotreotide (177Lu)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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