UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041106 |
|---|---|
| Receipt number | R000046945 |
| Scientific Title | Elucidation of the pathology of gynecological tumors using FES-PET |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/07/15 10:34:13 |
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Basic information
Public title
Elucidation of the pathology of gynecological tumors using FES-PET
Acronym
Elucidation of the pathology of gynecological tumors using FES-PET
Scientific Title
Elucidation of the pathology of gynecological tumors using FES-PET
Scientific Title:Acronym
Elucidation of the pathology of gynecological tumors using FES-PET
Region
| Japan |
Condition
Condition
gynecological tumor
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Differentiation between uterine fibroids and sarcoma,Determination of the effect of fertility-conserving treatment for early endometrial cancer and precancerous lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
It becomes possible to distinguish between uterine fibroids and sarcomas
Key secondary outcomes
It becomes possible to determine the indication and effect of fertility preservation treatment for early endometrial cancer and precancerous lesions
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Obtaining consent and then performing FES PET and FDGPET tests. One month before the start of treatment, measuring SUV values in tumors and Comparing with clinical data.
The method of administration and imaging as follows; after fasting from 5 hours ago, FES with a radiation isotope of 6 mCi, injected intravenously. After one hour, using a PET device capable of full body scanning of radiation, to image the accumulation of FES.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
The patients are patients with treatable uterine fibroids, uterine sarcoma, endometrial cancer, and endometrial hyperplasia.
Key exclusion criteria
When the subject requests to decline to participate in the test or withdraws her consent
If the pregnancy is found
If the entire exam is canceled
If, for other reasons, the doctor determines that it is appropriate to stop the examination
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshida |
| Middle name | |
| Last name | Yoshio |
Organization
Fukui University
Division name
Department of Obstetrics and Gynecology
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji Town, Yoshida
TEL
0776-61-8392
obgyn@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Tsuyoshi |
Organization
Fukui University
Division name
Department of Obstetrics and Gynecology
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji Town, Yoshida
TEL
0776-61-8392
Homepage URL
https://sankafujinka.com/fes/
obgyn@med.u-fukui.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Fukui University
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Fukui 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
Fukui University
Address
23-3 Matsuoka Shimoaizuki, Eiheiji Town, Yoshida
Tel
0776618392
obgyn@med.u-fukui.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
福井大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
| 2017 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 15 | Day |
Last modified on
| 2020 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046945
