UMIN-CTR Clinical Trial

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
Last 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
1st 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