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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006802
Receipt No. R000007984
Scientific Title Clinical study for monitoring of therapy effect on breast cancer using 18F-fluoromisonidazole PET/CT
Date of disclosure of the study information 2011/12/01
Last modified on 2019/04/01

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Basic information
Public title Clinical study for monitoring of therapy effect on breast cancer using 18F-fluoromisonidazole PET/CT
Acronym Monitoring of therapy effect on breast cancer using 18F-FMISO PET/CT
Scientific Title Clinical study for monitoring of therapy effect on breast cancer using 18F-fluoromisonidazole PET/CT
Scientific Title:Acronym Monitoring of therapy effect on breast cancer using 18F-FMISO PET/CT
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 An aim of this study is to monitor the therapy effect on breast cancer using FMISO PET/CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Relation between the shrinkage and the FMISO uptake in the breast cancer after 2-4 cycles of chemotherapy and after completion of therapy.
Key secondary outcomes Relation between the prognosis and the FMISO uptake in the breast cancer after 2-4 cycles of chemotherapy and after completion of therapy.

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
Medicine
Interventions/Control_1 PET/CT imaging 2 hrs after administration of F-18-fluoromisonidazole (FMISO) ( 7.4MBq/kg ) at 3 time points of pretherapy, 2-4 cycles after chemotherapy and posttherapy ( presurgery ).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with breast cancer who are eligible for surgical treatment.
2) Patients with breast cancer who are eligible for surgical treatment after presurgical treatment ( chmotherapy and/or hormone therapy ).
3) Patients who are consent to participate in this study
Key exclusion criteria 1) Pregnant female or female having possibility of pregnancy
2) Patients ineligible for participating in this study because of other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama International Medical Center, Saitama Medical University
Division name Department of Nuclear Medicine
Zip code 350-1298
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298
TEL 042-984-4147
Email kuji@saitama-med.ac.jp

Public contact
Name of contact person
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama International Medical Center, Saitama Medical University
Division name Clinical test assistant center
Zip code 350-1298
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298
TEL 042-984-4523
Homepage URL http://www.saitama-med.ac.jp/kokusai/support_center.html
Email chikens@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical University International Medical Center Crinical trial IRB
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298
Tel 042-984-4523
Email chikens@saitama-med.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 埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 43
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
2011 Year 11 Month 30 Day
Date of IRB
2011 Year 11 Month 09 Day
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 30 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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