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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020466
Receipt No. R000023640
Scientific Title Blood Oxygenation Level-Dependent (BOLD) Contrast Magnetic Resonance Imaging (MRI) for Prediction of Pancreas Cancer Chemoradiotherapy Response
Date of disclosure of the study information 2016/01/11
Last modified on 2020/03/06

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Basic information
Public title Blood Oxygenation Level-Dependent (BOLD) Contrast Magnetic Resonance Imaging (MRI) for Prediction of Pancreas Cancer Chemoradiotherapy Response
Acronym BOLD Contrast MRI for Prediction of Pancreas Cancer Chemoradiotherapy Response
Scientific Title Blood Oxygenation Level-Dependent (BOLD) Contrast Magnetic Resonance Imaging (MRI) for Prediction of Pancreas Cancer Chemoradiotherapy Response
Scientific Title:Acronym BOLD Contrast MRI for Prediction of Pancreas Cancer Chemoradiotherapy Response
Region
Japan

Condition
Condition Pancreas Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical value of BOLD contrast MRI in predicting the response of locally advanced pancreas cancer to chemoradiation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between BOLD response and tumor regression after chemoradiation
Key secondary outcomes Relationship between BOLD response and patient prognosis after chemoradiation

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histological confirmation of pancreas cancer
2) Scheduled to undergo chemoradiation for locally advanced pancreas cancer (T3-4, N0-1, M0 according to the International Union Against Cancer TNM system)
3) Written informed consent is obtained.
Key exclusion criteria 1-2) Contraindication to MRI (eg, noncompatible biometallic implants or claustrophobia)
3) During pregnancy
4) Chronic obstructive pulmonary disease
5) Heart failure
6) Less than 20 years of age
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshihiko
Middle name
Last name Fukukura
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Radiology
Zip code 89-8544
Address 8-35-1 Sakuragaoka, Kagoshima-shi
TEL 099-275-5417
Email fukukura@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Yoshihiko
Middle name
Last name Fukukura
Organization Kagoshima University Hospital
Division name Radiology
Zip code 89-8544
Address 8-35-1 Sakuragaoka, Kagoshima-shi
TEL 099-275-5417
Homepage URL
Email fukukura@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Department of Radiology, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kagoshima University Hospital
Address 8-35-1 Sakuragaoka, Kagoshima, Japan
Tel 099-275-6692
Email kufsyomu@kuas.kagoshima-u.ac.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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 11 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 Completed
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
2015 Year 12 Month 22 Day
Anticipated trial start date
2016 Year 01 Month 11 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information From January 2016 to March 2018, BOLD MRI exams are performed before chemoradiation to clarify the relationship between BOLD response and tumor regression after chemoradiotherapy in 40 patients who are scheduled to undergo chemoradiation for locally advanced pancreas cancer.

Management information
Registered date
2016 Year 01 Month 07 Day
Last modified on
2020 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023640

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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