UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061127 |
|---|---|
| Receipt number | R000069947 |
| Scientific Title | [18F]FDG PET in Breast Cancer: Exploratory Investigation of Clinicopathological Significance |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 15:17:59 |
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Basic information
Public title
[18F]FDG PET in Breast Cancer: Exploratory Investigation of Clinicopathological Significance
Acronym
[18F]FDG PET in Breast Cancer: Exploratory Investigation of Clinicopathological Significance
Scientific Title
[18F]FDG PET in Breast Cancer: Exploratory Investigation of Clinicopathological Significance
Scientific Title:Acronym
[18F]FDG PET in Breast Cancer: Exploratory Investigation of Clinicopathological Significance
Region
| Japan |
Condition
Condition
Patients with breast cancer or suspected breast cancerr
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the clinicopathological significance of [18F]FDG PET imaging in patients with breast cancer, we will conduct an exploratory study investigating its correlations with staging accuracy, tumor characteristics, and the tumor immune microenvironment (TIME).
Basic objectives2
Others
Basic objectives -Others
Exploration of the clinical significance of imaging findings
Diagnostic performance
Reproducibility
Effects of image processing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elucidation of the clinicopathological significance of PET findings
Key secondary outcomes
Extraction and reproducibility of PET findings
Optimization of PET image reconstruction methods
Correlations with other imaging and clinical findings
Application of advanced PET image processing and analysis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with confirmed or suspected breast cancer who underwent [18F]FDG PET imaging (using PET/CT, dedicated breast PET, and/or PET/MR) at the Department of Diagnostic Radiology, Kyoto University Hospital.
Female patients aged 18 years or older.
Key exclusion criteria
Individuals judged unsuitable for the study by the Principal Investigator, Sub-investigator, or Co-investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3760
diag_rad@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Miyake |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4748
Homepage URL
diag_rad@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto 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
Ethics Committee, Kyoto University Graduate School of Medicine, Faculty of Medicine and Kyoto University Hospital
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2028 | 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 retrospective observational study of patients with confirmed or suspected breast cancer who underwent [18F]FDG PET imaging (including PET/CT, dedicated breast PET, and/or PET/MR) at the Department of Diagnostic Radiology, Kyoto University Hospital, between April 1, 2009, and March 31, 2028.
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069947
