UMIN-CTR Clinical Trial

Basic information
Public title	Innovation of new diagnostic modalities for pancreatic cancer using PET-MRI
Acronym	PET-MRI for diagnosis of pancreatic cancer
Scientific Title	Innovation of new diagnostic modalities for pancreatic cancer using PET-MRI
Scientific Title:Acronym	PET-MRI for diagnosis of pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Our objectives are improvements of accuracy of the diagnostic procedures using PET-MRI, intraoperative elastography, intraoperative pancreatography using indocyanine green fluorescent pancreatography and postoperative immunohistochemical analysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of PET-MRI for diagnosis of pancreatic cancer compared to PET-CT
Key secondary outcomes	1)Efficay of elastography and indocyanine green fluorescent pancreatography for diagnosis of pancreatic cancer 2)incidence of pancreatic fistula

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Conventional PET-CT and ERCP are compared to PET-MRI and fluorescent pancreatography.
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)performance status:0-2 2)without dimentia or psychiatric disorder 3)T. Bil=<5.0 mg/dl, AST=<200 IU/L, ALT=<200 IU/L, serum creatinine=<1.5mg/dl 4)without acute pancreatitis 5)patients who agree this study on document of informed consent
Key exclusion criteria	1:Patients with contraindication for pilocarpine hydrochloride, such as severe ischemic heart disease, bronchial asthma, ileus, obstruction of urinary tract, epilepsy, Parkinsonism and Parkinson disease, iritis 2:Patients with allegy for indocyanine green
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiichi Takenoshita
Organization	Fukushima Medical University
Division name	Department of Organ Regulatory Surgery
Zip code
Address	1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
TEL	+81-24-547-1257
Email	takenoss@fmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuo Shimura
Organization	Fukushima Medical University
Division name	Department of Organ Regulatory Surgery
Zip code
Address	1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
TEL	+81-24-547-1259
Homepage URL
Email	tshimura@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Fukushima Medical University
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
Address
Tel
Email

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	福島県立医科大学病院（福島県）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2015 Year 01 Month 29 Day
Date of IRB	2017 Year 01 Month 31 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 10 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019289