UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016065 |
|---|---|
| Receipt number | R000018595 |
| Scientific Title | A pilot study for evaluating hypoxia area in pancreas cancer by 18F-FMISO PET/CT |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/03/17 18:59:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study for evaluating hypoxia area in pancreas cancer by 18F-FMISO PET/CT
Acronym
A pilot study for pancreas cancer by FMISO-PET/CT
Scientific Title
A pilot study for evaluating hypoxia area in pancreas cancer by 18F-FMISO PET/CT
Scientific Title:Acronym
A pilot study for pancreas cancer by FMISO-PET/CT
Region
| Japan |
Condition
Condition
Pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficiency of 18F-FDG-PET for the patients with pancreas cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the acquisition protocol of 18F-FMISO-PET/CT for pancreas cancer
To compare the result of 18F-FMISO-PET/CT with the other imaging modalities
To compare the result of 18F-FMISO-PET/CT with the clinical outcome
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
18F-FMISO-PET/CT
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) Patients with written informed consent
2) Patients who were diagnosed or suspected as pancreas cancer
3) Patients who have already acquired or were planned to acquire 18F-FDG-PET/CT
Key exclusion criteria
1) Patients with pregnancy or possibility of pregnancy
2) Patients who cannot keep supine position during the PET exam of approximately 30 minutes
3) Patients who were considered to be inappropriate to join this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Yamane |
Organization
Saitama International Medical Center, Saitama Medical University
Division name
Department of Nuclear Medicine
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
t_yamane@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Yamane |
Organization
Saitama International Medical Center, Saitama Medical University
Division name
Department of Nuclear Medicine
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
t_yamane@saitama-med.ac.jp
Sponsor or person
Institute
Saitama International Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama International Medical Center, Saitama 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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | 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
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018595
