UMIN-CTR Clinical Trial

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 Toshiki Middle name Last name Kazama
Organization	Tokai University Hospital
Division name	Department of Diagnostic Radiology
Zip code	259-1193
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 Toshiki Middle name Last name Kazama
Organization	Tokai University Hospital
Division name	Department of Diagnostic Radiology
Zip code	259-1193
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	Institutional Review Board for Clinical Research, Tokai University
Address	143 Shimo-Kasuya, Isehara, 259-1193, Japan
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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	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	Terminated
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	2022 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	2022 Year 11 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031319