UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020466 |
|---|---|
| Receipt number | 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 14:50:55 |
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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
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
fukukura@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023640
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
