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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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/

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name