UMIN-CTR Clinical Trial

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
Email	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
Email	t_yamane@saitama-med.ac.jp

Sponsor
Institute	Saitama International Medical Center, Saitama Medical University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018595