UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043313 |
|---|---|
| Receipt number | R000049439 |
| Scientific Title | Imaging evaluation of estrogen receptor in breast cancer |
| Date of disclosure of the study information | 2021/02/16 |
| Last modified on | 2022/02/06 15:42:26 |
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Basic information
Public title
Imaging evaluation of estrogen receptor in breast cancer
Acronym
Imaging evaluation of estrogen receptor in breast cancer
Scientific Title
Imaging evaluation of estrogen receptor in breast cancer
Scientific Title:Acronym
Imaging evaluation of estrogen receptor in breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictive values of [18F]fluoroestradiol ([18F]FES) PET for treatment efficacy and its prognostic impact in patients with breast cancer
Basic objectives2
Others
Basic objectives -Others
In this study, estrogen receptor expression status will be evaluated by [18F]FES-PET using PET/CT, dedicated breast PET, and PET/MRI, and its performance in the prediction of therapeutic effect and the patient prognosis will be examined. Comparison among PET systems and optimization of imaging methods, verification of pathological and clinical features related to [18F]FES accumulation, and construction of a diagnostic algorithm with other diagnostic examinations for breast cancer are included.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative and quantitative parameters of [18F]FES-PET will be correlated with patient prognosis, and with the therapeutic effects measured by image monitoring or pathological evaluation.
Key secondary outcomes
- Comparison among PET systems and optimization of examination methods and image reconstruction parameters
- Verification of pathological and clinical features related to [18F]FES accumulation
- Comparison and validation with existing diagnostic examinations for breast cancer
- Construction of a diagnostic algorithm using a multi-marker approach combining multiple tests
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
| Medicine | Device,equipment |
Interventions/Control_1
About 1-1.5 hr after [18F]FES injection (approximately 111-222 MBq), PET/CT, dedicated breast PET, and/or PET/MR scanning will be performed. A small amount of blood will be collected at the time of [18F]FES injection.
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
1. Patients over 20 years of age at the time of consent
2. Patients who have been diagnosed with breast cancer or have a strong clinical or imaging suspicion of breast cancer.
3. Patients who have completed the written informed consent
Key exclusion criteria
1. Patients who received selective estrogen receptor modulators (SERMs) or selective estrogen down regulators (SERDs) within 5 weeks prior to [18F] FES-PET
2. Patient who had adverse reactions to [18F]FES in the past
3. Women who are or may be pregnant
4. Patients in extremely poor general condition
5. Patients with significant communication difficulties
6. Patients judged not to be appropriate for attending this study by investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3760
ynakamo1@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | Kawai |
| Last name | Miyake |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Advanced Medical Imaging Research
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL
075-751-3760
Homepage URL
kanaek@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
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
| 2021 | Year | 02 | Month | 16 | 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
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2033 | Year | 03 | 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
| 2021 | Year | 02 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049439
