UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019336 |
|---|---|
| Receipt number | R000021465 |
| Scientific Title | Preliminary study for non-invasive measurement of estrogen receptor by [18F]FES-PET/CT |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2019/04/01 12:21:06 |
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Basic information
Public title
Preliminary study for non-invasive measurement of estrogen receptor by [18F]FES-PET/CT
Acronym
Measurement of estrogen receptor by FES-PET/CT
Scientific Title
Preliminary study for non-invasive measurement of estrogen receptor by [18F]FES-PET/CT
Scientific Title:Acronym
Measurement of estrogen receptor by FES-PET/CT
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of 18F-FES PET/CT for the breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) Validity of PET imaging process, b) relationship between the uptake in 18F-FES PET/CT and the pathological expression of estrogen receptor at primary lesion of breast cancer, and c) relationship between the uptake in 18F-FES PET/CT and the results of other imaging modalities, are evaluated by the visual comparison by radiologists and statistical analysis by the results of pathology and other imaging modalities, when 18F-FES PET/CT images of all the cases will be acquired.
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
18F-FES PET/CT, intravenous injection of 3.7MBq/kg of 18F-FES (max. 370MBq)
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
1) Patient who is diagnosed as breast cancer
2) Patient who has performed, or who will be perform pathological estrogen receptor evaluation in our hospital
3) Patient who have completed the written informed consent
Key exclusion criteria
1) Patient who is pregnant or who has the possibility of pregnancy
2) Patient who have difficulty in performing PET/CT exam by the severe pain or bad condition
3) Patient who are determined as not appropriate for attending this study by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Saitama Medical University International Medical Center
Division name
Nuclear Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka
TEL
042-984-4111
yamane_t@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Saitama Medical University International Medical Center
Division name
Nuclear Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka
TEL
042-984-4111
Homepage URL
yamane_t@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center Crinical trial IRB
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1298
Tel
042-984-4523
chikens@saitama-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021465
