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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007347
Receipt No. R000008660
Scientific Title Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST).
Date of disclosure of the study information 2012/03/01
Last modified on 2012/12/25

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Basic information
Public title Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST).
Acronym Feasibility study of dbPET
Scientific Title Feasibility study of dedicated breastPET(db PET) for evaluating therapeutic effects of primary systemic therapy (PST).
Scientific Title:Acronym Feasibility study of dbPET
Region
Japan

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

Objectives
Narrative objectives1 Evaluating the images obtained by dbPET, not whole body PET, in PST
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes FDG PET images on dbPET scan after the first cycle of PST.
Key secondary outcomes Comparison between db PET and MRI or pathologic findings of resected specimen

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 db 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 1. Female patients with primary breast cancer diagnosed by palpation, imagings and cytology, with T stage >=T1and M0.
2.The patinets should be scheduled to receive PST.
3.Female patients who can agree to participate in this study of their own will, and aged 20 years and older at the time of informed consent.
Key exclusion criteria 1. Patients with sever impairement in communications.
2. Patients with very poor general conditions (such as abnormal vital signs).
3. Patients who are pregnancy or suspicion of pregnancy.
4. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoharu Sugie
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Homepage URL
Email sugie@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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

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

Other administrative information
Date of disclosure of the study information
2012 Year 03 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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 05 Day
Last follow-up date
2014 Year 08 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
2012 Year 02 Month 21 Day
Last modified on
2012 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008660

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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