UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012517
Receipt number R000014651
Scientific Title A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer
Date of disclosure of the study information 2013/12/09
Last modified on 2019/03/31 11:55:10

* 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

A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer

Acronym

To evaluate the effectiveness of dbPET in patients undergoing neoadjuvant chemotherapy for breast cancer

Scientific Title

A prospective study to evaluate the effectiveness of dedicated breast positron emission tomography (dbPET) in patients undergoing neoadjuvant chemotherapy for breast cancer

Scientific Title:Acronym

To evaluate the effectiveness of dbPET in patients undergoing neoadjuvant chemotherapy for 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 evaluate the diagnostic ability of dedicated breast positron emission tomography (dbPET) can do predict the outcome of pathological results of the patients undergoing neoadjuvant chemotherapy for breast cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison with the pathological findings

Key secondary outcomes

Comparison with MRI diagnosis


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

Device,equipment

Interventions/Control_1

Perform dbPET scan for patients undergoing neoadjuvant chemotherapy for breast cancer, and to analyze the correlation between the FDG uptake of the lesions and pathological diagnosis or the MRI diagnosis.

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

Female

Key inclusion criteria

The patients undergoing neoadjuvant chemotherapy for breast cancer

Key exclusion criteria

1.Pregnant and possibly pregnant women
2.Other patients determined to be inappropriate by physician

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Sadatoshi
Middle name
Last name Sugae

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of gastroterological surgery

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan

TEL

045-787-2650

Email

sugae@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Sadatoshi
Middle name
Last name Sugae Sadatoshi

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of gastroterological surgery

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan

TEL

045-787-2650

Homepage URL


Email

sugae@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Department of gastroterological surgery, Graduate School of Medicine, Yokohama City 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

Department of gastroterological surgery, Graduate School of Medicine, Yokohama City University

Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan

Tel

045-787-2650

Email

sugae@yokohama-cu.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

2013 Year 12 Month 09 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

15

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

2013 Year 07 Month 29 Day

Date of IRB

2013 Year 10 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 09 Day

Last follow-up date

2018 Year 12 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 08 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014651


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name