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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027331
Receipt No. R000031319
Scientific Title Clarification of action mechanism of Halaven (Eribulin) using MRI
Date of disclosure of the study information 2017/05/15
Last modified on 2019/06/01

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Basic information
Public title Clarification of action mechanism of Halaven (Eribulin) using MRI
Acronym Clarification of action mechanism of Halaven using MRI
Scientific Title Clarification of action mechanism of Halaven (Eribulin) using MRI
Scientific Title:Acronym Clarification of action mechanism of Halaven using MRI
Region
Japan

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

Objectives
Narrative objectives1 To observe effect of Halaven on tumor microperfusion
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Perfusion of tumor before, 8 days-, 29 days-, 90 days- after start of Halaven treatment
Key secondary outcomes ADC and size of tumor before, 8 days-, 29 days-, 90 days- after start of Halaven treatment

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Advanced or metastatic breast cancer patients who are to be treated with Halaven at Tokai University Hospital
2. Patients with measurable lesions by contrast-enhanced MRI; lymph node metastasis, liver metastasis, or osteolytic bone metastasis with shortest dimension larger than 2cm.
3. Patients who can hold breath for 20 seconds and can follow instruction during MR examinations.
4. Patients who give written informed consent for this study.
Key exclusion criteria 1.Patients with concomitant radiation therapy for the target lesions.
2.Allergy to Gd-contrast.
3.Patients with asthma
4.Patients with renal dysfunction
5.Pregnant or breast feeding
6.Implanted metallic or electronic device not confirmed safety at 3T-MRI.
7.Patients with difficult venous access.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Kazama
Organization Tokai University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Email kazamat@fg7.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Kazama
Organization Tokai University Hospital
Division name Department of Diagnostic Radiology
Zip code
Address 143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL 0463-93-1121
Homepage URL
Email kazamat@fg7.so-net.ne.jp

Sponsor
Institute Tokai University Hospital
Institute
Department

Funding Source
Organization Tokai University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 東海大学医学部附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 15 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
2017 Year 03 Month 16 Day
Date of IRB
2017 Year 03 Month 18 Day
Anticipated trial start date
2017 Year 05 Month 17 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Pretreatment evaluation: contrast-enhanced MRI.
2. Eight days after start of Halaven treatment: contrast-enhanced MRI
3. Twenty-nine days after start of Halaven treatment: contrast-enhanced MRI
4. Approximately 90 days after start of Halaven treatment, or soon after judgment of PD: contrast-enhanced MRI

Management information
Registered date
2017 Year 05 Month 13 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031319

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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