UMIN-CTR Clinical Trial

Basic information
Public title	Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis and therapeutic assessment for esophageal cancer
Acronym	Diagnosis and therapeutic assessment for esophageal cancer with molecular imaging of DNA synthesis
Scientific Title	Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis and therapeutic assessment for esophageal cancer
Scientific Title:Acronym	Diagnosis and therapeutic assessment for esophageal cancer with molecular imaging of DNA synthesis
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of 4DST-PET for diagnosis, treatment planning and therapeutic assessment of esophageal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	To explore how 4DST-PET can contribute to initial diagnosis, treatment planning and therapeutic assessment of esophageal cancer.
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	Other
Interventions/Control_1	The patients undergo both 4DST- and FDG-PET studies. The findings will be compared reciprocally. In the procedure, other examinations including histopathological findings and other radiological images are referred.
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) Patient who is pathologically diagnosed as esophageal cancer. 2) Age, elder than or equal to 20 years. 3) Capability to undergo PET scan. 4) Completed the written informed consent.
Key exclusion criteria	1) Unable to have signed informed consent. 2) Patient with severe comorbid disease including liver dysfunction, renal dysfunction or metabolic damage. 3) Uncontrollable diabetics. 4) Those who are determined as not appropriate for the study by the principal investigator.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Department of Nuclear Medicine
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Ryogo Minamimoto
Organization	National Center for Global Health and Medicine
Division name	Department of Nuclear Medicine
Zip code
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	rminamimoto@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Government offices of other countries
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 10 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	2015 Year 07 Month 01 Day
Date of IRB	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date	2019 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	2015 Year 06 Month 24 Day
Last modified on	2019 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020909