UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopy
Title of the study (Brief title)	Dose finding study of fluorescein for pCLE
Region	Japan

Condition
Condition	gastrointestinal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To decide the optimal dose of fluorescein toduring probe based confocal endomicoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Visibility of duodenal or colon mucosa that is examined by pCLE with using different dose of fluorescein.
Key secondary outcomes	Adverse event with different dose of fluorescein.

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
Interventions/Control_1	Single dose adminstration of fluorescein to perform pCLE
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are scheduled to perform endoscopic resection or surgery for gastrointestinal tumors. Written informed consent is obtained. Laboratory data within 90 days before registration meet the criteria.
Key exclusion criteria	Contraindication to biopsy. Patients who can not stop anticoagulants. Allergy to fluorescein. Patients who have the history of pheochromocytoma, malignant hypertension, severe heart failure, myocardial infarction that has occured with in 3 months, uncontrolled diabetes, severe pulmonary fibrosis, active interstitial pneumonia, uncontrolled infection. Pregnant. Others who are judged as inappropriate by medical doctors.
Target sample size	24

Research contact person
Name of lead principal investigator	Yutaka Satio
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	ytsaito@ncc.go.jp

Public contact
Name of contact person	Kazuya Inoki
Organization	National Cancer Center Hospital
Division name	Endoscopy Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	kinoki@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2017 Year 06 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 08 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031725