Trial Title:
LUTATHERA Injection General Use Result Survey
NCT ID:
NCT05844332
Condition:
Somatostatin Receptor-positive Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Lutetium Lu 177 dotatate
Conditions: Keywords:
LUTATHERA
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
LUTATHERA
Description:
There is no treatment allocation. Patients administered LUTATHERA by prescription can be
enrolled.
Arm group label:
LUTATHERA
Other name:
Lutetium oxodotreotide (177Lu)
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).
Criteria for eligibility:
Study pop:
All patients treated with this drug for the following indications during a certain
post-marketing period
• Indication: Somatostatin receptor-positive neuroendocrine tumor
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nagoya
Zip:
464 8681
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hirosaki
Zip:
036 8563
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kamogawa
Zip:
296-8602
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kashiwa
Zip:
277 8577
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toon city
Zip:
791-0295
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukuoka city
Zip:
812-8582
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukushima city
Zip:
960 1295
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Gifu-city
Zip:
501-1194
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Maebashi city
Zip:
371 8511
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sapporo city
Zip:
060 8648
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sapporo
Zip:
060-8543
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Akashi
Zip:
673-8558
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kobe
Zip:
650-0047
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kanazawa
Zip:
920 8641
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kita-gun
Zip:
761-0793
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kagoshima city
Zip:
890 8520
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kamakura-city
Zip:
247-8533
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Yokohama-city
Zip:
236-0004
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sendai city
Zip:
980 8574
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Suwa
Zip:
392-8510
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kurashiki
Zip:
710-8602
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Okayama-city
Zip:
700-8558
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Osaka Sayama
Zip:
589 8511
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Osaka-city
Zip:
541-8567
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Suita
Zip:
565 0871
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hamamatsu
Zip:
431-3192
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Iwata
Zip:
438-8550
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sunto Gun
Zip:
411 8777
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Bunkyo-ku
Zip:
113-8519
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chuo ku
Zip:
104 0045
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Koto ku
Zip:
135 8550
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toyama-city
Zip:
930-0194
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chuo
Zip:
409-3898
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chiba
Zip:
260-8717
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukui
Zip:
910-8526
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukuoka
Zip:
814-0001
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hiroshima
Zip:
734-8551
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kobe-shi
Zip:
650-0017
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kumamoto
Zip:
860-8556
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kyoto
Zip:
606 8507
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Osaka
Zip:
553-0003
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Shizuoka
Zip:
420-8527
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tokushima
Zip:
770-8503
Country:
Japan
Facility:
Name:
Novartis Investigative Site
Address:
City:
Yamagata
Zip:
990 9585
Country:
Japan
Start date:
December 17, 2021
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844332
