UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062711 |
|---|---|
| Receipt number | R000071802 |
| Scientific Title | Establishment of a Dosimetry Protocol Using Post Lutetium (177Lu) vipivotide tetraxetan Treatment SPECT/CT Imaging |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/27 14:48:43 |
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Basic information
Public title
Establishment of a Dosimetry Protocol Using Post Pluvicto Treatment SPECT/CT Imaging
Acronym
SPECT/CT Imaging of Pluvicto Treatment
Scientific Title
Establishment of a Dosimetry Protocol Using Post Lutetium (177Lu) vipivotide tetraxetan Treatment SPECT/CT Imaging
Scientific Title:Acronym
Establishment of a Dosimetry Protocol Using Post PSMA Treatment SPECT/CT Imaging
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the distribution of the radiopharmaceutical used for treatment actually matches that observed on the PSMA-PET scan performed to determine treatment eligibility.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whole-body scintigraphy and SPECT/CT images of uptake sites will be acquired once or twice, specifically 24 hours and between 48 and 120 hours after the completion of Lutetium (177Lu) vipivotide tetraxetan administration. Quantitative assessment will be performed and compared with PSMA-PET.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Radiation exposure associated with the concurrent use of a CT scan for fusion imaging during SPECT acquisition.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients treated with Lutetium (177Lu) vipivotide tetraxetan
Key exclusion criteria
Patients unable to maintain the required body position for the necessary duration
Patients from whom consent cannot be obtained directly
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mana |
| Middle name | |
| Last name | Yoshimura |
Organization
Tokyo Medical University
Division name
Department of Radiology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
+81-333426111
radiolmn@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Yoshimura |
Organization
Tokyo Medical University
Division name
Department of Radiology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
+81-333426111
Homepage URL
radiolmn@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Mana Yoshimura
Funding Source
Organization
Tokyo Medical University
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
Tokyo Medical University
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
+81-333426111
adm_irb@tokyo-med.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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071802
