UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015839 |
|---|---|
| Receipt number | R000018431 |
| Scientific Title | Investigation of usefulness of molecular functional imaging to observe vascular remodeling and tumor oxygenation of breast cancer after start of eribulin mesylate |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2024/12/20 14:10:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of usefulness of molecular functional imaging to observe vascular remodeling and tumor oxygenation of breast cancer after start of eribulin mesylate
Acronym
functional imaging to observe vascular remodeling and tumor oxygenation of breast cancer after eribulin mesylate
Scientific Title
Investigation of usefulness of molecular functional imaging to observe vascular remodeling and tumor oxygenation of breast cancer after start of eribulin mesylate
Scientific Title:Acronym
functional imaging to observe vascular remodeling and tumor oxygenation of breast cancer after eribulin mesylate
Region
| Japan |
Condition
Condition
Unresectable locally advanced or metastatic breast cancer patients which need chemotherapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate molecular pathological effect and radiological response using diffuse optical spectroscopy to eribulin in breast cancer tumors
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of tissue oxygenation of breast cancer tumors to erubulin
Key secondary outcomes
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
Diffuse optical spectroscopy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who get informed consents on paper
Patients with 20 year old or more
Patients who had unresectable locally advanced (T4 or N2) or metastatic breast cancer
Patients who already recieved anthracycline and taxane chemotherapy
Key exclusion criteria
Patients whom doctor consider the treatment is suitable for
Patients who have uncontroled infection
Patients who had severe AEs prior to chemotherapy
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama medical university International medical center
Division name
Dept of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
81-42-984-4670
tsaeki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto UEDA |
Organization
Saitama International Medical Center
Division name
Department of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
81-42-984-4670
Homepage URL
syueda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical univeristy international medical center
Institute
Department
Personal name
Funding Source
Organization
Eisai Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018431
