LUTATHERA Injection General Use Result Survey

Completed

• Conditions: Somatostatin Receptor-positive Neuroendocrine Tumor
• Interventions: Other: LUTATHERA

• Registration Number: NCT05844332
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is 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 will be examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).

Study Timeline

• Study Start: 2021-12-17
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LUTATHERA	LUTATHERA	patients treated with LUTATHERA Injection

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Yamagata, Japan