UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027331
Receipt number 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 2022/11/20 15:43:01

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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 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 or person

Institute

Tokai University Hospital

Institute

Department

Personal name



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

Value
https://center6.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