UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039200
Receipt number R000044705
Scientific Title Multicenter prospective study of dedicated breast positron emission tomography for breast cancer
Date of disclosure of the study information 2020/01/20
Last modified on 2024/01/24 14:39:20

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Basic information

Public title

Multicenter prospective study of dedicated breast positron emission tomography for breast cancer

Acronym

Multicenter prospective study of dedicated breast positron emission tomography for breast cancer

Scientific Title

Multicenter prospective study of dedicated breast positron emission tomography for breast cancer

Scientific Title:Acronym

Multicenter prospective study of dedicated breast positron emission tomography for breast cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To find out which patient group and clinical condition are more useful in dbPET imaging method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Breast cancer detection rate

Key secondary outcomes

To assess dbPET images and patient background
To assess dbPET images and other imaging methods
To assess dbPET images and histological findings


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who can agree to participate in this study of their own will, and have given consent in writing, and aged 20 years and older at the time of informed consent.

Key exclusion criteria

Patients who cannot maintain rest in the position. abdominal position
Patients who are pregnancy or suspicion of pregnancy at the time of dbPET inspection.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Nagano
Middle name
Last name Hiroaki

Organization

Yamaguchi university graduate school of medicine

Division name

Department of Gastorenterological, Breast and Endocrine Surgery

Zip code

7558505

Address

1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken

TEL

0836222264

Email

geka2dm@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Noriko
Middle name
Last name Maeda

Organization

Yamaguchi university

Division name

Department of Gastroenterological, Breast and Endcrine Surgery

Zip code

7558505

Address

1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken

TEL

0836222264

Homepage URL


Email

geka2dm@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi university

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi 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

Center For Clinical Research, Yamaguchi University Hospital

Address

1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken

Tel

0836222428

Email

clin_res@yamaguchi-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

2020 Year 01 Month 20 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

Open public recruiting

Date of protocol fixation

2019 Year 12 Month 27 Day

Date of IRB

2019 Year 12 Month 25 Day

Anticipated trial start date

2020 Year 01 Month 20 Day

Last follow-up date

2026 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To find out which patient group and clinical condition are more useful in dbPET imaging method.


Management information

Registered date

2020 Year 01 Month 20 Day

Last modified on

2024 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name