UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057478 |
|---|---|
| Receipt number | R000065636 |
| Scientific Title | Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy and Development of the Practical Manual |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 13:02:24 |
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Basic information
Public title
Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy
Acronym
Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy
Scientific Title
Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy and Development of the Practical Manual
Scientific Title:Acronym
Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy
Region
| Japan |
Condition
Condition
Neuroendocrine tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Standardization of Dosimetry in 177Lu Targeted Radionuclide Therapy and Development of the Practical Manual in Japan
Basic objectives2
Others
Basic objectives -Others
To determine the evaluation points to simulate the dosimetry of 177Lu-DOTATE.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is whether the renal dose error using the two-point method (simulation using 24,168 hours' data after 177Lu-DOTATATE injection) is acceptable (within the allowable error) compared to the four-point method using 4,24,96, and 168 hours' data after the injection.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: >19 years
Laboratory Tests (within 1 month before treatment):
eGFR >50 mL/min
Hemoglobin >10 g/dL
White blood cell count 3000-10000/microliter
Platelet count >75000/microliter
Albumin >3 g/dL
Bilirubin <3 mg/dL
Cognitive Function: Hasegawa Dementia Scale (HDS-R) score >20
Ability to take oral nutrition independently
Ability to manage insulin therapy and medication independently
Ability to manage urination (use of pads or other aids is acceptable if necessary)
WHO Performance Status: 0-1
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1) Presence of urgent findings on chest or abdominal CT.
2) History of hypersensitivity to Lu-DOTATE, L-lysine hydrochloride, or L-arginine hydrochloride.
3) Pregnant or breastfeeding women, or women with the potential for pregnancy who are not using appropriate contraception.
4) Men with a partner who has the potential for pregnancy and who are not using appropriate contraception.
5) Patients with endogenous psychiatric disorders, such as schizophrenia, or those with psychiatric symptoms that would make study participation difficult.
6) The presence of an active systemic infection requires treatment.
7) Inability to maintain a stable position for more than 30 minutes.
8) Any other medical, psychological, or other factors that the principal investigator deems inappropriate for participation.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Murai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Radiation Oncology
Zip code
2478533
Address
1370-1 Okamoto, Kamakura, Japan
TEL
0467461717
t_murai@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Murai |
Organization
Shonan Kamakura General Hospital
Division name
Department of Radiation Oncology
Zip code
2478533
Address
1370-1 Okamoto, Kamakura, Japan
TEL
09033008419
Homepage URL
t_murai@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant, Japanese Society for Radiation Oncology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
ccts_kyoyu38@shonankamakura.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2447
Org. issuing International ID_1
The Tokushukai Group Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Software simulates patients' organ dosimetry using different time points. These calculated doses are compared with each other.
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065636
