UMIN-CTR Clinical Trial

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