UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between FDG PET finding and oncologic gene mutation in hepatic/cholangic/pancreatic tumors
Acronym	FDG PET and oncologic mutation in hepatic/cholangic/pancreatic tumors
Scientific Title	Relationship between FDG PET finding and oncologic gene mutation in hepatic/cholangic/pancreatic tumors
Scientific Title:Acronym	FDG PET and oncologic mutation in hepatic/cholangic/pancreatic tumors
Region	Japan

Condition
Condition	malignant tumor of liver, bile duct system and pancreas.
Classification by specialty	Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To varidate the effect of cancer related gene and its mutation on FDG uptake measured on PET imaging.
Basic objectives2	Others
Basic objectives -Others	Evaluation of effectiveness of iamging and its improvement.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical diagnosis, finding of FDG PET imaging and measured uptake of FDG. Pathological parameters measured on cancer sample such as invasiveness. Expression glucose transporter, hexokinese and G-6-Pase on cancer tissue. Expression and mutation of cancer related genes such as p53 on cancer tissue.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who were performed resection of hepatic/chorangic and pancreatic cancer and also performed FDG PET imaging during July 2010 and Sept 2014.
Key exclusion criteria	1: Patient with FDG PET image quality which is too poor to interpret. 2: The cases which the cancer tissue is not available.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kudo
Organization	Atomic bomb disease institute, Nagasaki University
Division name	Department of Radioisotope medicine
Zip code	8528523
Address	12-4 Sakamoto 1-chome, Nagasaki
TEL	095-819-7101
Email	tkudo123@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kudo
Organization	Atomic bomb disease institute, Nagasaki University
Division name	Department of Radioisotope medicine
Zip code	8528523
Address	12-4 Sakamoto 1-chome, Nagasaki
TEL	095-819-7101
Homepage URL
Email	tkudo123@nagasaki-u.ac.jp

Sponsor
Institute	Atomic bomb disease institute, Nagasaki University
Institute
Department

Funding Source
Organization	Atomic bomb disease institute, Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital
Address	1-12-4 Sakamoto, Nagasaki
Tel	095-819-7726
Email	rinshou7726@umin.ac.jp

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	2014 Year 12 Month 04 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	48
Results	Now, analysis not including genome information are on going. Correlation between FDG uptake and histological infromation regarding tumor invasion (except lymphatic invasion) were observed in pancreatic cancer.
Results date posted	2021 Year 05 Month 27 Day
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	Main results already published
Date of protocol fixation	2014 Year 10 Month 08 Day
Date of IRB	2014 Year 10 Month 08 Day
Anticipated trial start date	2014 Year 12 Month 04 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is retrospective observation study. In this study, we compare FDG uptake measured on FDG PET imaging preoperatively and cancer related gene expression and mutations. Also evaluate relationship between FDG uptake and glusoce metabolism related factor, factor which affect on radiation sensitivity.

Management information
Registered date	2014 Year 11 Month 21 Day
Last modified on	2021 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018306