UMIN-CTR Clinical Trial

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
Last 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
Email	yamane_t@saitama-med.ac.jp

Public contact
1st 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
Email	yamane_t@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021465