UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006802 |
|---|---|
| Receipt number | 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 12:43:36 |
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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
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
chikens@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007984
