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LUTATHERA Injection General Use Result Survey

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05844332
Collaborator
(none)
300
Enrollment
7
Locations
61.5
Anticipated Duration (Months)
42.9
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: LUTATHERA

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)
Actual Study Start Date :
Dec 16, 2021
Anticipated Primary Completion Date :
Jan 31, 2027
Anticipated Study Completion Date :
Jan 31, 2027

Arms and Interventions

Arm Intervention/Treatment
LUTATHERA

patients treated with LUTATHERA Injection

Other: LUTATHERA
There is no treatment allocation. Patients administered LUTATHERA by prescription can be enrolled.
Other Names:
  • Lutetium oxodotreotide (177Lu)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Kashiwa Chiba Japan 277 8577
    2 Novartis Investigative Site Gifu-city Gifu Japan 501-1194
    3 Novartis Investigative Site Osaka Sayama Osaka Japan 589 8511
    4 Novartis Investigative Site Chuo-city Yamanashi Japan 409-3898
    5 Novartis Investigative Site Chiba Japan 260-8717
    6 Novartis Investigative Site Fukui Japan 910-8526
    7 Novartis Investigative Site Kyoto Japan 606 8507

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05844332
    Other Study ID Numbers:
    • CAAA601A11401
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Novartis Pharmaceuticals
    LUTATHERA
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Lutetium Lu 177 dotatate

    Study Results

    No Results Posted as of May 6, 2023