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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043313
Receipt No. R000049439
Scientific Title Imaging evaluation of estrogen receptor in breast cancer
Date of disclosure of the study information 2021/02/16
Last modified on 2021/02/12

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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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients between 20 and 85 years old at the time of obtaining consent
2. Patients who have been diagnosed with breast cancer or have a strong clinical or imaging suspicion of breast cancer.
3. Patients with pathological diagnosis of estrogen receptor-positive tumors or lobular carcinoma from primary or metastatic sites
4. 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 60 days 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
Email 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
Email kanaek@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
2021 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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