UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058835 |
|---|---|
| Receipt number | R000067279 |
| Scientific Title | Validation of Dynamic SPECT Imaging Using the StarGuide Dedicated SPECT System |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/19 13:26:39 |
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Basic information
Public title
Validation of Dynamic SPECT Imaging Using the StarGuide Dedicated SPECT System
Acronym
Validation of Dynamic SPECT Imaging Using the StarGuide Dedicated SPECT System
Scientific Title
Validation of Dynamic SPECT Imaging Using the StarGuide Dedicated SPECT System
Scientific Title:Acronym
Validation of Dynamic SPECT Imaging Using the StarGuide Dedicated SPECT System
Region
| Japan |
Condition
Condition
Renal dysfunction
Classification by specialty
| Nephrology | Urology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify that dynamic SPECT imaging with the StarGuide dedicated SPECT system can reproduce the examinations conventionally performed with renal scintigraphy.
Basic objectives2
Others
Basic objectives -Others
This is a technical verification study and does not aim to evaluate clinical efficacy or safety. We will confirm whether dynamic SPECT with the StarGuide system can reproduce key metrics of conventional renal scintigraphy (TAC, ERPF, GFR, differential renal function, excretion patterns).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification that the renal time-activity curves obtained from dynamic SPECT imaging with StarGuide are comparable to those from conventional renal scintigraphy.
Consistency between the two methods in the following renal function parameters:
Effective renal plasma flow (ERPF)
Glomerular filtration rate (GFR)
Excretion patterns
Differential renal function values
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Patients who have undergone conventional renal scintigraphy will additionally undergo dynamic imaging using the dedicated SPECT system StarGuide with 99mTc-DTPA or 99mTc-MAG3, in order to confirm the feasibility of acquiring dynamic renal SPECT images. The radiopharmaceutical and imaging protocol for renal scintigraphy will be the same as those conventionally used. Clinical examinations of the patient will be conducted both before and after administration.
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
Patients who have provided written informed consent to participate in this study
Patients scheduled to undergo, or who have undergone, renal scintigraphy with 99mTc-DTPA or 99mTc-MAG3 for clinical renal function assessment
Adults aged 20 years or older
Individuals judged eligible for participation by the principal investigator or sub-investigator
Key exclusion criteria
Patients who are pregnant or potentially pregnant
Patients who are expected to have difficulty remaining still during imaging
Patients whom the principal investigator judges to be inappropriate for participation in this study (e.g., when any therapeutic intervention for the kidneys has been performed between the initial renal scintigraphy and the imaging in this study)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Toyama |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
9808575
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai city, Miyagi
TEL
+81-22-717-7312
ytoyama0818@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Toyama |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
9808575
Address
1-1 Seiryo-machi, Aoba-Ku, Sendai city, Miyagi
TEL
+81-22-717-7312
Homepage URL
ytoyama0818@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of Tohoku University Hospital
Address
2-1 Seiryo-machi, Aoba-Ku, Sendai city, Miyagi
Tel
+81-22-728-4105
ec-hosp@grp.tohoku.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
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067279
