UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016679 |
|---|---|
| Receipt number | R000019289 |
| Scientific Title | Innovation of new diagnostic modalities for pancreatic cancer using PET-MRI |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2019/10/01 11:54:16 |
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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
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
tshimura@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019289
| 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 |
