UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063029 |
|---|---|
| Receipt number | R000072154 |
| Scientific Title | An observational study to evaluate the clinical utility of dosimetry in lutetium-177 radionuclide therapy |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/23 16:55:29 |
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Basic information
Public title
An observational study to evaluate the clinical utility of dosimetry in lutetium-177 radionuclide therapy
Acronym
An observational study to evaluate the clinical utility of dosimetry in lutetium-177 radionuclide therapy
Scientific Title
An observational study to evaluate the clinical utility of dosimetry in lutetium-177 radionuclide therapy
Scientific Title:Acronym
An observational study to evaluate the clinical utility of dosimetry in lutetium-177 radionuclide therapy
Region
| Japan |
Condition
Condition
Patients who received Lu-177-labeled radionuclide therapy
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In patients who received Lu-177-labeled radionuclide therapy, we will perform dosimetry of tumors and organs based on post-administration tracer uptake measured with SPECT, and evaluate the association of the absorbed doses with treatment response and the occurrence of adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After Lu-177-labeled radionuclide therapy, SPECT imaging will be performed to estimate the absorbed doses to tumors and various organs.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to receive Lu-177-labeled radionuclide therapy who provide written informed consent to participate in this study.
Key exclusion criteria
1) Minors
2) Patients who did not provide consent to participate in this study
3) Patients judged by the principal investigator or other investigators to be ineligible for this study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Iwabuchi |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
iwabuchi@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Iwabuchi |
Organization
Keio University School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
iwabuchi@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Office, Keio University School of Medicine
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-5363-3236
ocr@crea.hosp.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study. In patients scheduled to receive Lu-177-labeled radionuclide therapy, SPECT/CT imaging will be performed after administration of the therapeutic agent to calculate the absorbed doses to tumors and organs (e.g., kidneys and bone marrow), and the association of these doses with treatment response and adverse events will be evaluated.
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072154
