UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014173
Receipt number R000016509
Scientific Title 18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer
Date of disclosure of the study information 2014/07/01
Last modified on 2015/06/05 13:56:16

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Basic information

Public title

18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer

Acronym

18F-FMISO PET imaging in metastatic breast cancer

Scientific Title

18F-FMISO PET imaging and efficacy of eribulin in metastatic breast cancer

Scientific Title:Acronym

18F-FMISO PET imaging in metastatic breast cancer

Region

Japan


Condition

Condition

metastatic breast cancer

Classification by specialty

Breast surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate tumor hypoxia and efficacy of eribulin using 18F-FMISO PET in metastatic breast cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SUV level of FMISO PET and the change after treatment of eribulin

Key secondary outcomes



Base

Study type


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

Interventions/Control_1

18F-FMISO PET

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

patients over 20y.o. with evaluatable lesion of metastatic breast cancer who were planned eribulin treatment

Key exclusion criteria

none

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroko Yamashita

Organization

Hokkaido University Hospital

Division name

breast surgery

Zip code


Address

N14 W5 Kita-ku Sapporo city

TEL

011-706-7381

Email

hosodam@seagreen.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuchika Hosoda

Organization

Hokkaido University Hospital

Division name

breast surgery

Zip code


Address

N14 W5 Kita-ku Sapporo city

TEL

011-706-7381

Homepage URL


Email

hosodam@seagreen.ocn.ne.jp


Sponsor or person

Institute

breast surgery Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

eizal inc

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

北海道大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 07 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

2014 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 05 Day

Last modified on

2015 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name