UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017682 |
|---|---|
| Receipt number | R000020495 |
| Scientific Title | Prospective evaluation of clinical feasibility of PET-MRCP in diagnosis of biliary stricture |
| Date of disclosure of the study information | 2015/05/30 |
| Last modified on | 2016/11/25 14:54:02 |
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Basic information
Public title
Prospective evaluation of clinical feasibility of PET-MRCP in diagnosis of biliary stricture
Acronym
PET-MRCP for biliary stricture
Scientific Title
Prospective evaluation of clinical feasibility of PET-MRCP in diagnosis of biliary stricture
Scientific Title:Acronym
PET-MRCP for biliary stricture
Region
| Japan |
Condition
Condition
Malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the clinical feasibitly of PET-MRI in diagnosis of malignant biliary stricture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy distinguishing benign and milignant biliary stricture
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Preliminary study: we will perform PET-MRI in 2 healthy volunteers to determine optimal setting to detect biliary tract. Main study: we will prospectively recruite 30 cases with biliary stricture and prospectively evaluate diagnostic feasibility of PET-MRI in diagnosing bening and malignant biliary stricture
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with biliary stricture on US, CT or MRI.
2) Patients without any histroy of biliary drainage.
3) Performance status 0 to 2
4) No severe liver and kidney dysfunction (TB<5 mg/dl, AST/ALT<200 IU/L, Serum creatinin<1.5 mg/dl.
5) No history of recent infection (WBC 3000-9000, CRP<1.0 mg/dl)
6) Patients who agree to participate in this study with written informed consent
Key exclusion criteria
Patients who do not meet inclusion criteria above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Ohira |
Organization
Fukushima Medical University
Division name
Gastroenterology and Rheumatology
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
subaru@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadayuki Takagi |
Organization
Fukushima Medical University
Division name
Gastroenterology and Rheumatology
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
Homepage URL
subaru@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Bristol Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 30 | 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 | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020495
