UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027374 |
|---|---|
| Receipt number | R000031369 |
| Scientific Title | Efficacy of Positron Emission Mammography in evaluating clinical response after preoperative chemotherapy |
| Date of disclosure of the study information | 2017/05/17 |
| Last modified on | 2020/05/20 09:35:11 |
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Basic information
Public title
Efficacy of Positron Emission Mammography in evaluating clinical response after preoperative chemotherapy
Acronym
Efficacy of Positron Emission Mammography in evaluating clinical responce after preoperative chemotherapy
Scientific Title
Efficacy of Positron Emission Mammography in evaluating clinical response after preoperative chemotherapy
Scientific Title:Acronym
Efficacy of Positron Emission Mammography in evaluating clinical responce after preoperative chemotherapy
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess whether or not to improve the rates of predicting residual lesions after preoperatieve chemotherapy by using PEM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Sensitivity(pCR(pT0))
Key secondary outcomes
Specificity
Positive predictive value
Negative predictive value
Accuracy
Relation between the point of SUV and pCR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PEM
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Early breast cancer patients receiving preoperative chemotherapy
Key exclusion criteria
Allergy with FDG
Patients holding pacemaker
Patients with pregnancy or breastfeeding
Patients with diabetes
Patients with difficult of taking PEM
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Gondo |
Organization
Aichi Cancer Hospital
Division name
Breast Oncology
Zip code
4648681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya-city, Aichi, Japan
TEL
052-762-6111
ngondou@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Iwase |
Organization
Aichi Cancer Center
Division name
Breast Oncology
Zip code
4648681
Address
1-1, Kanokoden, Chikusa-ku, Nagoya-city, Aichi, Japan
TEL
052-762-6111
Homepage URL
miwase@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Radiological Diagnosis Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AIchi Cancer Center
Address
1-1 Kanookoden, Chikusa-ku, Nagoya-city, Aichi Japan
Tel
0527626111
irb@aichi-cc.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
愛知県がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 17 | 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
50
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
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 25 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2020 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031369
